Extensive Stage Lung Small Cell Carcinoma Clinical Trial
Official title:
Combination Chemotherapy With or Without Maintenance Sunitinib Malate (NSC 736511) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study
Verified date | March 2023 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This partially randomized phase I/II trial studies the side effects and best dose of sunitinib malate and to see how well it works when given together with cisplatin or carboplatin and etoposide in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cisplatin or carboplatin and etoposide are more effective when given with or without sunitinib malate in treating small cell lung cancer.
Status | Completed |
Enrollment | 156 |
Est. completion date | August 20, 2015 |
Est. primary completion date | June 30, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients must have histologically or cytologically documented small cell lung cancer - Eligible disease stages: the extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive stage patients are defined as those patients with extrathoracic metastatic, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy - All patients must have measurable disease: - Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan - Lesions that are considered non-measurable, which would make the patient not eligible, include the following: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Lymphangitis cutis/pulmonis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - No prior chemotherapy for small cell lung cancer (SCLC) - Radiation therapy must have been completed at least one week before initiation of protocol therapy - Common Toxicity Criteria (CTC) performance status: - Phase IB: 0-1 - Phase II: 0-2 - No "currently active" second malignancy other than non-melanoma skin cancers - No history of brain metastases, spinal cord compression, or carcinomatous meningitis - No ongoing cardiac dysrhythmias, atrial fibrillation, or QTc interval >= 500 msec; the use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, pedridel, haloperidol, risperidone, indapamide, flecainide) is not recommended while on protocol therapy - Patients with class I New York Heart Association (NYHA) are eligible; patients with a history of class II NYHA are eligible, provided they meet the following criteria: - Patients with a history of class II heart failure who are asymptomatic on treatment - Patients with prior anthracycline exposure - Patients who have received central thoracic radiation that included the heart in the radiotherapy port - Patients with a history of class III or IV NYHA heart failure within 12 months prior to registration are not eligible - Additionally, no myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft or stenting, cerebrovascular accident including transient ischemic attack, or pulmonary embolism within the last year - Patients with hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal medical therapy) are not eligible - Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis; Note: Low molecular weight heparin is permitted provided the patient's prothrombin time (PT) international normalized ratio (INR) is =< 1.5 - No evidence of hemoptysis within 4 weeks prior to starting study treatment; patients with blood-tinged or blood streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 mL of blood per episode and less than 10 mL of blood per 24-hour period in the best estimate of the investigator - None of the following within 28 days of treatment: abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious or non-healing wound, ulcer, or bone fracture - The use of the following specific inhibitors and inducers of cytochrome p450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not permitted; the following inhibitors of CYP3A4 are prohibited within 7 days before and during treatment with sunitinib: azole antifungals (ketoconazole, itraconazole), diltiazem, clarithromycin, erythromycin, verapamil, delavirdine, and human immunodeficiency virus (HIV) protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir); the following inducers of CYP3A4 are prohibited within 12 days before beginning and during treatment with sunitinib: rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John's Wort, efavirenz, tipranavir - Other inhibitors and inducers of CYP3A4 may be used if necessary, but there use is discouraged - Non-pregnant and non-nursing - Granulocytes >= 1,500/ul - Platelets >= 100,000/ul - Creatinine clearance >= 70 ml/min - Total bilirubin =< 1.5 mg/dl - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) (patients w/ liver metastases may have AST/ALT =< 5 x ULN) - Partial thromboplastin time (PTT) =< 1.5 x ULN |
Country | Name | City | State |
---|---|---|---|
United States | Arroyo Grande Community | Arroyo Grande | California |
United States | PCR Oncology | Arroyo Grande | California |
United States | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | Beaufort Memorial Hospital | Beaufort | South Carolina |
United States | Central Vermont Medical Center/National Life Cancer Treatment | Berlin | Vermont |
United States | Illinois CancerCare-Bloomington | Bloomington | Illinois |
United States | Saint Joseph Medical Center | Bloomington | Illinois |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Vermont and State Agricultural College | Burlington | Vermont |
United States | Cooper Hospital University Medical Center | Camden | New Jersey |
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 | East Bay Radiation Oncology Center | Castro Valley | California |
United States | Valley Medical Oncology Consultants-Castro Valley | Castro Valley | California |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | University of Missouri - Ellis Fischel | Columbia | Missouri |
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | New Hampshire Oncology Hematology PA-Concord | Concord | New Hampshire |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | Heartland Cancer Research NCORP | Decatur | Illinois |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Hematology Oncology Associates of Central New York-East Syracuse | East Syracuse | New York |
United States | Elkhart Clinic | Elkhart | Indiana |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Michiana Hematology Oncology PC-Elkhart | Elkhart | Indiana |
United States | Union Hospital of Cecil County | Elkton | Maryland |
United States | Bay Area Breast Surgeons Inc | Emeryville | California |
United States | Eureka Hospital | Eureka | Illinois |
United States | Illinois CancerCare-Eureka | Eureka | Illinois |
United States | McLeod Regional Medical Center | Florence | South Carolina |
United States | Holy Cross Hospital | Fort Lauderdale | Florida |
United States | Fort Wayne Medical Oncology and Hematology Inc-Parkview | Fort Wayne | Indiana |
United States | Valley Medical Oncology Consultants-Fremont | Fremont | California |
United States | Florida Cancer Specialists-Gainesville Cancer Center | Gainesville | Florida |
United States | Galesburg Cottage Hospital | Galesburg | Illinois |
United States | Illinois CancerCare-Galesburg | Galesburg | Illinois |
United States | Glens Falls Hospital | Glens Falls | New York |
United States | Addison Gilbert Hospital | Gloucester | Massachusetts |
United States | Wayne Memorial Hospital | Goldsboro | North Carolina |
United States | CHI Health Saint Francis | Grand Island | Nebraska |
United States | Illinois CancerCare-Havana | Havana | Illinois |
United States | Mason District Hospital | Havana | Illinois |
United States | Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | New Hampshire Oncology Hematology PA-Hooksett | Hooksett | New Hampshire |
United States | Hopedale Medical Complex - Hospital | Hopedale | Illinois |
United States | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | Jupiter Medical Center | Jupiter | Florida |
United States | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois |
United States | Kewanee Hospital | Kewanee | Illinois |
United States | Community Howard Regional Health | Kokomo | Indiana |
United States | AMITA Health Adventist Medical Center | La Grange | Illinois |
United States | IU Health La Porte Hospital | La Porte | Indiana |
United States | LRGHealthcare-Lakes Region General Hospital | Laconia | New Hampshire |
United States | Beebe Medical Center | Lewes | Delaware |
United States | Nebraska Cancer Research Center | Lincoln | Nebraska |
United States | Illinois CancerCare-Macomb | Macomb | Illinois |
United States | Mcdonough District Hospital | Macomb | Illinois |
United States | Contra Costa Regional Medical Center | Martinez | California |
United States | Mount Sinai Medical Center | Miami Beach | Florida |
United States | Minneapolis VA Medical Center | Minneapolis | Minnesota |
United States | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota |
United States | Michiana Hematology Oncology PC-Mishawaka | Mishawaka | Indiana |
United States | Saint Joseph Regional Medical Center-Mishawaka | Mishawaka | Indiana |
United States | Holy Family Medical Center | Monmouth | Illinois |
United States | Illinois CancerCare-Monmouth | Monmouth | Illinois |
United States | El Camino Hospital | Mountain View | California |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Ralph Lauren Center for Cancer Care and Prevention | New York | New York |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | Lakeland Hospital Niles | Niles | Michigan |
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 | Great Plains Health Callahan Cancer Center | North Platte | Nebraska |
United States | Alta Bates Summit Medical Center - Summit Campus | Oakland | California |
United States | Bay Area Tumor Institute | Oakland | California |
United States | Hematology and Oncology Associates-Oakland | Oakland | California |
United States | Highland General Hospital | Oakland | California |
United States | Tom K Lee Inc | Oakland | California |
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 | Omaha | Nebraska |
United States | Nebraska Methodist Hospital | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Ottawa Regional Hospital and Healthcare Center | Ottawa | Illinois |
United States | Illinois CancerCare-Pekin | Pekin | Illinois |
United States | OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois |
United States | Pekin Hospital | Pekin | Illinois |
United States | Illinois CancerCare-Peoria | 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 | FirstHealth of the Carolinas-Moore Regional Hospital | Pinehurst | North Carolina |
United States | Michiana Hematology Oncology PC-Plymouth | Plymouth | Indiana |
United States | Illinois CancerCare-Princeton | Princeton | Illinois |
United States | Perry Memorial Hospital | Princeton | Illinois |
United States | Miriam Hospital | Providence | Rhode Island |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | OSF Saint Anthony Medical Center | Rockford | Illinois |
United States | Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan |
United States | Marie Yeager Cancer Center | Saint Joseph | Michigan |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Peninsula Regional Medical Center | Salisbury | Maryland |
United States | UCSF Medical Center-Mount Zion | San Francisco | California |
United States | Doctors Medical Center- JC Robinson Regional Cancer Center | San Pablo | California |
United States | Memorial Health University Medical Center | Savannah | Georgia |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Michiana Hematology Oncology PC-South Bend | South Bend | Indiana |
United States | Northern Indiana Cancer Research Consortium | South Bend | Indiana |
United States | South Bend Clinic | South Bend | Indiana |
United States | Illinois CancerCare-Spring Valley | Spring Valley | Illinois |
United States | Saint Margaret's Hospital | Spring Valley | Illinois |
United States | Iredell Memorial Hospital | Statesville | North Carolina |
United States | State University of New York Upstate Medical University | Syracuse | New York |
United States | MedStar Georgetown University Hospital | Washington | District of Columbia |
United States | Michiana Hematology Oncology PC-Westville | Westville | Indiana |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Plasma Levels of VEGF Prior to, During Single-agent, and Following Treatment With Sunitinib Malate | The frequency of tumor response by the optimally dichotomized VEGF levels will be tabulated and their association will be tested by Fisher's exact test as well as the maximally selected rank test. The association of the VEGF levels as continuous predictor with tumor response will be tested by Wilcoxon rank sum test. Further assessments of the association of the VEGF levels as> continuous or binary variables and the tumor response will be implemented in a logistic regression while adjusting for other covariates such as performance status, weight loss and age | Baseline to within 7 days of sunitinib/placebo therapy discontinuation | |
Other | Change in Plasma Levels of PDGF | Correlated with clinical outcome (response and survival). | Baseline to within 7 days of sunitinib/placebo therapy discontinuation | |
Primary | Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I) | The maximum tolerated dose is defined at the highest sunitinib dose at which less than one third of participants develop a dose limiting toxicity (DLT). A DLT is defined as: delay of beginning cycle 2 of chemotherapy by > 7 days due to neutropenia, grade 4 hematologic toxicity lasting greater than 1 week (chemotherapy alone would be expected to cause significant grade 4 hematologic toxicity) or grade 3 or 4 nonhematologic toxicity (excluding grade 3 or 4 fatigue if the patient is found to be hypothyroid and responds to fatigue < grade 3 with thyroid replacement therapy). | 21 days | |
Primary | Progression-free Survival (Phase II) | Progression free survival (PFS) was defined as the time from maintenance randomization to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method. | Up to 3 years | |
Secondary | Overall Survival | Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method. | Up to 3 years | |
Secondary | Number of Participants With Overall Tumor Response | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs. | Up to 3 years |
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