Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
Three-Arm Randomized Phase II Study of Carboplatin and Paclitaxel in Combination With Cetuximab, IMC-A12 or Both in Patients With Advanced Non-Small Cell Lung Cancer Who Will Not Receive Bevacizumab-Based Therapy
This randomized phase II trial is studying how well giving carboplatin and paclitaxel together with cetuximab and/or cixutumumab (IMC-A12) works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with monoclonal antibody therapy may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel are more effective when given with cetuximab and/or cixutumumab in treating non-small cell lung cancer.
Status | Completed |
Enrollment | 140 |
Est. completion date | December 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) - Stage IIIB disease - T4, NX with nodule in ipsilateral lung lobe allowed provided patient is not a candidate for combined chemotherapy and radiotherapy - Stage IV disease (includes M1a and M1b) - Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria - Ineligible for or refused treatment with bevacizumab - No untreated or symptomatic central nervous system (CNS) metastases - Patients with a history of CNS metastases that are definitively treated, stable, and controlled are eligible provided the following criteria are met: - Definitive therapy (surgery and/or radiotherapy) has been administered - Not planning to undergo additional treatment for brain metastases - Clinically stable - Off corticosteroids or on a stable dose of corticosteroids for = 14 days before study entry - ECOG performance status 0-1 - Leukocytes > 3,000/mm^3 - Absolute neutrophil count (ANC) > 1,500/mm^3 - Hemoglobin > 9 g/dL - Platelet count > 100,000/mm^3 - Total bilirubin = 1.5 times upper limit of normal (ULN) - Aspartate Aminotransferase (AST) < 3 times ULN (< 5 times ULN if elevations due to liver metastases) - Creatinine < 1.5 times ULN OR creatinine clearance > 60 mL/min - Fasting serum glucose < 120 mg/dL - Partial thromboplastin time (PTT) = 1.2 times ULN and international normalized ratio (INR) = 1.5 (unless patient is on anticoagulation therapy) - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after the last dose of cixutumumab - No poorly controlled diabetes mellitus - Patients with a history of diabetes mellitus are eligible provided their blood glucose is within normal range and they are on a stable dietary or therapeutic regimen for this condition - No other prior or concurrent malignancy, except for the following: - Curatively treated malignancy with no known active disease for = 3 years AND is considered to be at low risk for recurrence by the treating physician - Adequately treated nonmelanoma skin cancer or lentigo maligna with no evidence of disease - Adequately treated cervical carcinoma in situ with no evidence of disease - Prostatic intraepithelial neoplasia with no evidence of prostate cancer - Concurrent therapeutic anticoagulation allowed provided there is no bleeding and patient is on a stable dose of anticoagulation therapy (e.g., Warfarin with an INR of 2-3) for > 2 weeks prior to study entry - At least 21 days since prior radiotherapy - More than 4 weeks since prior major surgery or hormonal therapy (other than hormone replacement therapy) and recovered - More than 1 year since prior neoadjuvant or adjuvant chemotherapy Exclusion criteria: - Small cell lung cancer or mixed small cell and NSCLC - History of allergic reactions attributed to compounds of similar chemical or biological composition to cixutumumab - History of any medical or psychiatric condition, addictive disorder, or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study treatments or may interfere with the conduct of the study or interpretation of study results - Prior agents targeting the EGFR or Insulin-like growth factor (IGFR) pathways - Prior therapy for advanced NSCLC, except for surgery and/or radiotherapy - Prior systemic therapy, including bevacizumab for advanced stage NSCLC - Pregnant or nursing - Peripheral neuropathy > grade 1 as per Common Terminology Criteria for Adverse Event (CTCAE) v 4.0 - History of or suspected interstitial pneumonitis or pulmonary fibrosis on imaging - Significant uncontrolled cardiac disease within the past 6 months, including any of the following: - Uncontrolled hypertension (BP > 150/100 mm Hg) - Unstable angina - Recent myocardial infarction - Uncontrolled congestive heart failure - Cardiomyopathy with decreased ejection fraction - Arterial thrombosis, pulmonary embolus, deep vein thrombosis, or hemorrhagic disorders within the past 28 days |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Bixby Medical Center | Adrian | Michigan |
United States | Hickman Cancer Center | Adrian | Michigan |
United States | Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio |
United States | New York Oncology Hematology PC - Albany | Albany | New York |
United States | New York Oncology Hematology PC -Albany Medical Center | Albany | New York |
United States | New York Oncology Hematology PC - Amsterdam | Amsterdam | New York |
United States | Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Fox Valley Hematology and Oncology | Appleton | Wisconsin |
United States | The Medical Center of Aurora | Aurora | Colorado |
United States | Greater Baltimore Medical Center | Baltimore | Maryland |
United States | Mary Rutan Hospital | Bellefontaine | Ohio |
United States | Constantinou, Costas L MD (UIA Investigator) | Bettendorf | Iowa |
United States | Illinois CancerCare-Bloomington | Bloomington | Illinois |
United States | Saint Joseph Medical Center | Bloomington | Illinois |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Toledo Clinic Cancer Centers-Bowling Green | Bowling Green | Ohio |
United States | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Graham Hospital Association | Canton | Illinois |
United States | Illinois CancerCare-Canton | Canton | Illinois |
United States | Illinois CancerCare-Carthage | Carthage | Illinois |
United States | Memorial Hospital | Carthage | Illinois |
United States | Cedar Rapids Oncology Association | Cedar Rapids | Iowa |
United States | Mercy Hospital | Cedar Rapids | Iowa |
United States | Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa |
United States | Cancer Center of Kansas - Chanute | Chanute | Kansas |
United States | West Virginia University Charleston | Charleston | West Virginia |
United States | University of Virginia | Charlottesville | Virginia |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | North Coast Cancer Care-Clyde | Clyde | Ohio |
United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
United States | Columbus CCOP | Columbus | Ohio |
United States | Doctors Hospital | Columbus | Ohio |
United States | Grant Medical Center | Columbus | Ohio |
United States | Mount Carmel Health Center West | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | Mercy Hospital | Coon Rapids | Minnesota |
United States | Danbury Hospital | Danbury | Connecticut |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Oakwood Hospital | Dearborn | Michigan |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Colorado Cancer Research Program CCOP | Denver | Colorado |
United States | Exempla Saint Joseph Hospital | Denver | Colorado |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado |
United States | Rose Medical Center | Denver | Colorado |
United States | Saint John Hospital and Medical Center | Detroit | Michigan |
United States | Cancer Center of Kansas - Dodge City | Dodge City | Kansas |
United States | Essentia Health Duluth Clinic CCOP | Duluth | Minnesota |
United States | Essentia Health Saint Mary's Medical Center | Duluth | Minnesota |
United States | Miller-Dwan Hospital | Duluth | Minnesota |
United States | Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin |
United States | Fairview-Southdale Hospital | Edina | Minnesota |
United States | Cancer Center of Kansas - El Dorado | El Dorado | Kansas |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Hematology Oncology Center Incorporated | Elyria | Ohio |
United States | Swedish Medical Center | Englewood | Colorado |
United States | Green Bay Oncology - Escanaba | Escanaba | Michigan |
United States | Eureka Hospital | Eureka | Illinois |
United States | Illinois CancerCare-Eureka | Eureka | Illinois |
United States | Evanston CCOP-NorthShore University HealthSystem | Evanston | Illinois |
United States | Hunterdon Medical Center | Flemington | New Jersey |
United States | Genesys Regional Medical Center-West Flint Campus | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
United States | Vanderbilt-Ingram Cancer Center Cool Springs | Franklin | Tennessee |
United States | Fredericksburg Oncology Inc | Fredericksburg | Virginia |
United States | Unity Hospital | Fridley | Minnesota |
United States | Illinois CancerCare Galesburg | Galesburg | Illinois |
United States | Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin |
United States | Saint Mary's Hospital | Green Bay | Wisconsin |
United States | Saint Vincent Hospital | Green Bay | Wisconsin |
United States | Saint Francis Hospital and Medical Center | Hartford | Connecticut |
United States | Illinois CancerCare-Havana | Havana | Illinois |
United States | Mason District Hospital | Havana | Illinois |
United States | Geisinger Medical Center-Cancer Center Hazelton | Hazleton | Pennsylvania |
United States | Hinsdale Hematology Oncology Associates Incorporated | Hinsdale | Illinois |
United States | New York Oncology Hematology PC-Hudson | Hudson | New York |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | Indiana University Medical Center | Indianapolis | Indiana |
United States | Richard L. Roudebush Veterans Affairs Medical Center | Indianapolis | Indiana |
United States | Wishard Hospital | Indianapolis | Indiana |
United States | Green Bay Oncology - Iron Mountain | Iron Mountain | Michigan |
United States | Allegiance Health | Jackson | Michigan |
United States | UW Cancer Center Johnson Creek | Johnson Creek | Wisconsin |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois |
United States | Cancer Center of Kansas-Kingman | Kingman | Kansas |
United States | Community Howard Regional Health | Kokomo | Indiana |
United States | Gundersen Lutheran | La Crosse | Wisconsin |
United States | Indiana University Health La Porte Hospital | La Porte | Indiana |
United States | IU Health Arnett | Lafayette | Indiana |
United States | Saint Anthony Hospital | Lakewood | Colorado |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Lancaster General Hospital | Lancaster | Pennsylvania |
United States | Sparrow Hospital | Lansing | Michigan |
United States | Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | New York Oncology Hematology PC - Latham | Latham | New York |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Cancer Center of Kansas-Liberal | Liberal | Kansas |
United States | Lima Memorial Hospital | Lima | Ohio |
United States | Nebraska Cancer Research Center | Lincoln | Nebraska |
United States | Saint Mary Mercy Hospital | Livonia | Michigan |
United States | Sky Ridge Medical Center | Lone Tree | Colorado |
United States | Longmont United Hospital | Longmont | Colorado |
United States | McKee Medical Center | Loveland | Colorado |
United States | Illinois CancerCare-Macomb | Macomb | Illinois |
United States | Mcdonough District Hospital | Macomb | Illinois |
United States | Medical Center of Central Georgia | Macon | Georgia |
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
United States | UW Health Oncology - 1 South Park | Madison | Wisconsin |
United States | Manchester Memorial Hospital | Manchester | Connecticut |
United States | Holy Family Memorial Hospital | Manitowoc | Wisconsin |
United States | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota |
United States | Saint John's Hospital - Healtheast | Maplewood | Minnesota |
United States | Marietta Memorial Hospital | Marietta | Ohio |
United States | Bay Area Medical Center | Marinette | Wisconsin |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Saint Luke's Hospital | Maumee | Ohio |
United States | Toledo Clinic Cancer Centers-Maumee | Maumee | Ohio |
United States | Toledo Radiation Oncology at Northwest Ohio Onocolgy Center | Maumee | Ohio |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
United States | Saint Joseph Regional Medical Center-Mishawaka | Mishawaka | Indiana |
United States | Garneau, Stewart C MD (UIA Investigator) | Moline | Illinois |
United States | Porubcin, Michael MD (UIA Investigator) | Moline | Illinois |
United States | Sharis, Christine M MD (UIA Investigator) | Moline | Illinois |
United States | Spector, David MD (UIA Investigator) | Moline | Illinois |
United States | Stoffel, Thomas J MD (UIA Investigator) | Moline | Illinois |
United States | Trinity Medical Center | Moline | Illinois |
United States | Holy Family Medical Center | Monmouth | Illinois |
United States | Illinois CancerCare-Monmouth | Monmouth | Illinois |
United States | Community Cancer Center of Monroe | Monroe | Michigan |
United States | Mercy Memorial Hospital | Monroe | Michigan |
United States | Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly | New Jersey |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | Nashville Oncology Associates PC | Nashville | Tennessee |
United States | Licking Memorial Hospital | Newark | Ohio |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Cancer Center of Kansas - Newton | Newton | Kansas |
United States | Bromenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center Foundation | Normal | Illinois |
United States | Illinois CancerCare-Community Cancer Center | Normal | Illinois |
United States | Fisher-Titus Medical Center | Norwalk | Ohio |
United States | Green Bay Oncology - Oconto Falls | Oconto Falls | Wisconsin |
United States | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska |
United States | Alegent Health Immanuel Medical Center | Omaha | Nebraska |
United States | Creighton University Medical Center | Omaha | Nebraska |
United States | Missouri Valley Cancer Consortium CCOP | Omaha | Nebraska |
United States | UHHS-Chagrin Highlands Medical Center | Orange Village | Ohio |
United States | Saint Charles Hospital | Oregon | Ohio |
United States | Toledo Clinic Cancer Centers-Oregon | Oregon | Ohio |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Ottawa Regional Hospital and Healthcare Center | Ottawa | Illinois |
United States | Paoli Memorial Hospital | Paoli | Pennsylvania |
United States | Cancer Center of Kansas - Parsons | Parsons | Kansas |
United States | Illinois CancerCare-Pekin | Pekin | Illinois |
United States | Pekin Cancer Treatment Center | Pekin | Illinois |
United States | Pekin Hospital | Pekin | Illinois |
United States | Illinois CancerCare-Peoria | Peoria | Illinois |
United States | Illinois Oncology Research Association CCOP | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | Proctor Hospital | Peoria | Illinois |
United States | Illinois CancerCare-Peru | Peru | Illinois |
United States | Illinois Valley Hospital | Peru | Illinois |
United States | Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Albert Einstein Medical Center | Philadelphia | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Saint Joseph Mercy Oakland | Pontiac | Michigan |
United States | Saint Joseph Mercy Port Huron | Port Huron | Michigan |
United States | Pottstown Memorial Medical Center | Pottstown | Pennsylvania |
United States | Cancer Center of Kansas - Pratt | Pratt | Kansas |
United States | Illinois CancerCare-Princeton | Princeton | Illinois |
United States | Perry Memorial Hospital | Princeton | Illinois |
United States | Saint Mary Corwin Medical Center | Pueblo | Colorado |
United States | New York Oncology Hematology PC - Rexford | Rexford | New York |
United States | Marshfield Clinic at James Beck Cancer Center | Rhinelander | Wisconsin |
United States | Marshfield Clinic-Rice Lake Center | Rice Lake | Wisconsin |
United States | North Memorial Medical Health Center | Robbinsdale | Minnesota |
United States | Saint Mary's of Michigan | Saginaw | Michigan |
United States | Marie Yeager Cancer Center | Saint Joseph | Michigan |
United States | Metro-Minnesota CCOP | Saint Louis Park | Minnesota |
United States | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota |
United States | United Hospital | Saint Paul | Minnesota |
United States | Cancer Center of Kansas - Salina | Salina | Kansas |
United States | North Coast Cancer Care | Sandusky | Ohio |
United States | Mercy Hospital | Scranton | Pennsylvania |
United States | Scranton Hematology Oncology | Scranton | Pennsylvania |
United States | Saint Francis Regional Medical Center | Shakopee | Minnesota |
United States | Mercy Medical Center-Sioux City | Sioux City | Iowa |
United States | Saint Luke's Regional Medical Center | Sioux City | Iowa |
United States | Siouxland Hematology Oncology Associates | Sioux City | Iowa |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Northern Indiana Cancer Research Consortium | South Bend | Indiana |
United States | Illinois CancerCare-Spring Valley | Spring Valley | Illinois |
United States | Saint Margaret's Hospital | Spring Valley | Illinois |
United States | Springfield Regional Medical Center | Springfield | Ohio |
United States | Lakeland Hospital | St. Joseph | Michigan |
United States | Stanford University Hospitals and Clinics | Stanford | California |
United States | Geisinger Medical Group | State College | Pennsylvania |
United States | Marshfield Clinic Cancer Care at Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Green Bay Oncology - Sturgeon Bay | Sturgeon Bay | Wisconsin |
United States | Flower Hospital | Sylvania | Ohio |
United States | Scott and White Memorial Hospital | Temple | Texas |
United States | North Suburban Medical Center | Thornton | Colorado |
United States | Mercy Hospital of Tiffin | Tiffin | Ohio |
United States | Mercy Saint Anne Hospital | Toledo | Ohio |
United States | Saint Vincent Mercy Medical Center | Toledo | Ohio |
United States | The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio |
United States | Toledo Clinic Cancer Centers-Toledo | Toledo | Ohio |
United States | Toledo Community Hospital Oncology Program CCOP | Toledo | Ohio |
United States | University of Toledo | Toledo | Ohio |
United States | New York Oncology Hematology PC - Troy | Troy | New York |
United States | Natalie Warren Bryant Cancer Center at Saint Francis | Tulsa | Oklahoma |
United States | Virtua West Jersey Hospital Voorhees | Voorhees | New Jersey |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
United States | Marshfield Clinic-Wausau Center | Wausau | Wisconsin |
United States | Fulton County Health Center | Wauseon | Ohio |
United States | Cancer Center of Kansas - Wellington | Wellington | Kansas |
United States | Saint Ann's Hospital | Westerville | Ohio |
United States | UHHS-Westlake Medical Center | Westlake | Ohio |
United States | Marshfield Clinic - Weston Center | Weston | Wisconsin |
United States | Exempla Lutheran Medical Center | Wheat Ridge | Colorado |
United States | Wheeling Hospital | Wheeling | West Virginia |
United States | Associates In Womens Health | Wichita | Kansas |
United States | Cancer Center of Kansas - Main Office | Wichita | Kansas |
United States | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas |
United States | Via Christi Regional Medical Center | Wichita | Kansas |
United States | Wichita CCOP | Wichita | Kansas |
United States | Geisinger Wyoming Valley | Wilkes-Barre | Pennsylvania |
United States | Rice Memorial Hospital | Willmar | Minnesota |
United States | Cancer Center of Kansas - Winfield | Winfield | Kansas |
United States | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin |
United States | Riverview Hospital | Wisconsin Rapids | Wisconsin |
United States | Minnesota Oncology and Hematology PA-Woodbury | Woodbury | Minnesota |
United States | Lankenau Hospital | Wynnewood | Pennsylvania |
United States | Mainline Health CCOP | Wynnewood | Pennsylvania |
United States | Genesis HealthCare System | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival | Progression free survival is defined as time from registration to disease progression or death from any cause, whichever occurred earlier. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions . All eligible and treated patients were included in the analysis. |
Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3 | No |
Secondary | Overall Survival | Overall survival is defined as time from registration to death from any cause. | assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3 | No |
Secondary | Response Rate | Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR. | Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3 | No |
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