Fallopian Tube Cancer Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Phase II Study of VTX-2337 in Combination With Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Verified date | September 2019 |
Source | Celgene |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the overall survival of patients treated with
VTX-2337 + pegylated liposomal doxorubicin (PLD) versus those treated with PLD alone in women
with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal
cancer.
VTX-2337, a small molecule agonist of Toll-like Receptor 8 (TLR8), activates multiple
components of the innate immune system and is being developed as a novel therapeutic agent
for use in oncology. Experimental data obtained in an animal model of ovarian cancer supports
the combination of VTX-2337 with PLD. In this model, the combination of VTX-2337 and PLD
resulted in a significant reduction in tumor growth compared to either agent alone and an
increase in the number of T lymphocytes infiltrating the tumor. The combination of PLD and
VTX-2337 has been tested in a small number of women with ovarian cancer in a Phase 1b study
and appears to be generally well-tolerated.
Status | Completed |
Enrollment | 297 |
Est. completion date | July 31, 2016 |
Est. primary completion date | July 31, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. 2. Patients with the following histologic cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial adenocarcinoma, transitional cell carcinoma, malignant Brenner's tumor or adenocarcinoma not otherwise specified. 3. Patient must have measurable disease as defined by RECIST 1.1. 4. Patients must have received treatment with a platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment. Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease. Patients are allowed to have received, but are not required to have received, biologic/targeted therapy (e.g., bevacizumab and/or PARP inhibitor) as part of their primary treatment regimen or for management of recurrent or persistent disease. 5. Patients must have platinum-resistant disease, defined as having a platinum-free interval (PFI) of < 12 months after first- or second-line platinum-based chemotherapy, or having disease progression while receiving second-line platinum-based chemotherapy. 6. Patients must have adequate bone marrow, renal, hepatic, and neurologic functions as defined by the following: - Bone marrow function: absolute neutrophil count (ANC) = 1,500/mm3. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets = 100,000/mm3. Hemoglobin = 9 g/dL. - Renal function: creatinine = 1.5 x institutional upper limit normal (ULN). - Hepatic function: bilirubin < 1.2 mg/dL, SGOT (AST) and SGPT (ALT) = 3.0 x ULN and alkaline phosphatase = 2.5 x ULN. 7. Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy: - Patients should be free of active infection requiring parenteral antibiotics. - Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted. - Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted agents and immunologic agents, must be discontinued at least three weeks prior to registration. - Any prior radiation therapy must be completed at least four weeks prior to registration. 8. Patients must have a GOG performance status of 0 or 1. 9. Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry. 10. Patients must meet the entry requirements and undergo the baseline procedures. 11. Patients must have signed an IRB-approved informed consent form and authorization permitting release of personal health information. Exclusion Criteria: 1. Patients who have had treatment with VTX-2337, doxorubicin, PLD, or any other anthracycline. 2. Patients who have received an investigational agent < 30 days prior to registration. 3. Patients who have received oral or parenteral corticosteroids < 2 weeks prior to registration or who require ongoing systemic immunosuppressive therapy for any reason. 4. Patients with active autoimmune disease. "Active" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis. 5. Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of the other malignancy being present within the last three years. 6. Patients who have received prior radiotherapy OTHER THAN for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years are excluded. 7. Patients who have received prior chemotherapy OTHER THAN for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years are excluded. 8. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study. 9. Patients with clinically significant cardiovascular disease. 10. Patients who are pregnant or nursing. 11. Patients under the age of 18. 12. Patients with clinical symptoms or signs of gastrointestinal obstruction and/or who require parenteral hydration or nutrition. |
Country | Name | City | State |
---|---|---|---|
United States | Abington Memorial Hospital; Hanjani Institute for Gynecologic Oncology | Abington | Pennsylvania |
United States | Summa Health System | Akron | Ohio |
United States | Women's Cancer Care Associates | Albany | New York |
United States | Southwest Gynecologic Oncology Associates | Albuquerque | New Mexico |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | McFarland Clinic | Ames | Iowa |
United States | St. Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Mid Atlantic Pelvic Surgery Associates | Annandale | Virginia |
United States | Hope Women's Cancer Center | Asheville | North Carolina |
United States | Northside Hospital | Atlanta | Georgia |
United States | Georgia Regents University | Augusta | Georgia |
United States | University of Colorado Cancer Center | Aurora | Colorado |
United States | Greater Baltimore Medical Center | Baltimore | Maryland |
United States | Johns Hopkins Medical Institution | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | University of Maryland Medical Center | Baltimore | Maryland |
United States | Bronson Battle Creek | Battle Creek | Michigan |
United States | SUNY Downstate Medical Center | Brooklyn | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Providence Saint Joseph Medical Center | Burbank | California |
United States | Alamance Regional Cancer Center | Burlington | North Carolina |
United States | Lahey Hospital & Medical Center | Burlington | Massachusetts |
United States | Cooper University Hospital | Camden | New Jersey |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Carolinas Medical Center / Levine Cancer Institute | Charlotte | North Carolina |
United States | Northwestern University - Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Fairview Hospital Moll Pavilion Cancer Center | Cleveland | Ohio |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Ellis Fischel Cancer Center - University of Missouri | Columbia | Missouri |
United States | Ohio State University Medical Center | Columbus | Ohio |
United States | Carolinas Medical Center - Northeast | Concord | North Carolina |
United States | Minnesota Oncology Coon Rapids Clinic | Coon Rapids | Minnesota |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Karmanos Cancer Institute - Wayne State University | Detroit | Michigan |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Northeast Georgia Medical Center | Gainesville | Georgia |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | Grand Rapids Clinical Oncology | Grand Rapids | Michigan |
United States | Gynecologic Oncology of West Michigan | Grand Rapids | Michigan |
United States | Saint Mary's Health Care | Grand Rapids | Michigan |
United States | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan |
United States | Green Bay Oncology at St. Mary's Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology at St. Vincent's Hospital | Green Bay | Wisconsin |
United States | St Vincent Hospital | Green Bay | Wisconsin |
United States | Bon Secours St. Francis Hospital | Greenville | South Carolina |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Hartford Hospital | Hartford | Connecticut |
United States | St. Francis Hospital and Medical Center | Hartford | Connecticut |
United States | Kaiser Permanente Medical Center | Hayward | California |
United States | Sudarshan K. Sharma, MD, LTD | Hinsdale | Illinois |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | The Methodist Hospital | Houston | Texas |
United States | Indiana University Medical Center | Indianapolis | Indiana |
United States | St. Vincent Gynecologic Oncology | Indianapolis | Indiana |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | St. Dominic-Jackson Memorial Hospital | Jackson | Mississippi |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Women's Cancer Center at Kettering Medical Center | Kettering | Ohio |
United States | Monter Cancer Center | Lake Success | New York |
United States | Memorial Medical Center | Las Cruces | New Mexico |
United States | Women's Cancer Care Center of Nevada | Las Vegas | Nevada |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Winthrop P. Rockefeller Cancer Institute - University of Arkansas | Little Rock | Arkansas |
United States | Long Beach Memorial Medical Center | Long Beach | California |
United States | Central Georgia Gynecologic Oncology | Macon | Georgia |
United States | University of Wisconsin-Madison | Madison | Wisconsin |
United States | North Shore University Hospital | Manhasset | New York |
United States | Holy Family Memorial Medical Center | Manitowoc | Wisconsin |
United States | Bay Area Medical Center | Marinette | Wisconsin |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Hillcrest Hospital - Cleveland Clinic | Mayfield Heights | Ohio |
United States | Lake University Seidman Cancer Center | Mentor | Ohio |
United States | Aurora St. Luke's Medical Center Gynecologic Oncology | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Abbott Northwestern Hospital | Minneapolis | Minnesota |
United States | Mercy Health Partners - Mercy Campus | Muskegon | Michigan |
United States | The Hospital of Central Connecticut | New Britain | Connecticut |
United States | Yale - New Haven Hospital | New Haven | Connecticut |
United States | Long Island Jewish Medical Center | New Hyde Park | New York |
United States | Columbia University Medical Center | New York | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | NYU Langone Medical Center - Cancer Institute | New York | New York |
United States | Kaiser Permanente Medical Center | Oakland | California |
United States | Peggy and Charles Stephenson Cancer Center | Oklahoma City | Oklahoma |
United States | MD Anderson Cancer Center - Orlando | Orlando | Florida |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | University of Pennsylvania Medical Center | Philadelphia | Pennsylvania |
United States | St. Joseph's Hospital and Medical Center | Phoenix | Arizona |
United States | Hillman Cancer Center - University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Western Pennsylvania Hospital | Pittsburgh | Pennsylvania |
United States | Women and Infants Hospital of Rhode Island | Providence | Rhode Island |
United States | Reed City Hospital - Spectrum Health | Reed City | Michigan |
United States | Virginia Gynecology Oncology | Richmond | Virginia |
United States | Carilion Clinic Gynecological Oncology | Roanoke | Virginia |
United States | Kaiser Permanente Medical Center | Roseville | California |
United States | Kaiser Permanente Medical Center | Sacramento | California |
United States | Sutter Cancer Center | Sacramento | California |
United States | Metro Minnesota Clinical Oncology Program | Saint Louis Park | Minnesota |
United States | Park Nicollet Frauenshuh Cancer Center | Saint Louis Park | Minnesota |
United States | Minnesota Oncology Hematology - St. Paul Cancer Center | Saint Paul | Minnesota |
United States | Women's Cancer Associates | Saint Petersburg | Florida |
United States | Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah |
United States | Kaiser Permanente Medical Center | San Francisco | California |
United States | Kaiser Permanente Medical Center | San Jose | California |
United States | Kaiser Permanente Medical Center | Santa Clara | California |
United States | Memorial Health University Medical Center | Savannah | Georgia |
United States | St. Joseph's - Candler Gynecologic Oncology | Savannah | Georgia |
United States | Maine Medical Partners Women's Health | Scarborough | Maine |
United States | Northwest Hospital - UW Medicine | Seattle | Washington |
United States | Pacific Gynecology Specialists | Seattle | Washington |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | University of Washington Medical Center | Seattle | Washington |
United States | Women's Cancer Care of Seattle | Seattle | Washington |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Kaiser Permanente Medical Center | South San Francisco | California |
United States | Gibbs Cancer Center | Spartanburg | South Carolina |
United States | Stanford University School of Medicine | Stanford | California |
United States | Gynecologic Oncology of Central New York - SUNY Upstate | Syracuse | New York |
United States | Munson Medical Center | Traverse City | Michigan |
United States | Tulsa Cancer Institute | Tulsa | Oklahoma |
United States | Carle Cancer Center | Urbana | Illinois |
United States | Kaiser Permanente Medical Center | Vallejo | California |
United States | Kaiser Permanente Medical Center | Walnut Creek | California |
United States | Aspirus Regional Cancer Center | Wausau | Wisconsin |
United States | Reading Hospital (McGlinn Family Regional Cancer Center) | West Reading | Pennsylvania |
United States | University of Kansas Medical Center | Westwood | Kansas |
United States | Wake Forest University Health Science | Winston-Salem | North Carolina |
United States | Woodbury Clinic - CornerStone Medical Specialty Centre | Woodbury | Minnesota |
United States | University of Massachusetts Memorial Healthcare | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Celgene | Gynecologic Oncology Group |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | Comparison of duration of survival between the 2 treatment groups | Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact. | |
Secondary | Progression-free Survival (PFS) | Comparison of PFS between the 2 treatment groups | Progression-free survival is measured from enrollment and randomization on the study until first indication of progression based on irRECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment. | |
Secondary | Frequency and Severity of Adverse Events (AEs) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can be unfavorable and unintended sign, symptom, or disease which is temporally associated with the use of investigational product (IP), whether or not considered related to the IP. A serious AE = an AE occurring at any dose that: • Results in death • Is life- threatening • Requires or prolongs existing inpatient hospitalization • Results in persistent or significant disability/incapacity • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to IP and graded the severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0: Grade (GR) 1 = Mild; asymptomatic or mild symptoms; GR 2 = Moderate (minimal, local or noninvasive intervention indicated); GR 3 = Severe or medically significant; GR 4 = Life-threatening; GR 5 = Death | Assessed during each cycle of therapy and within 30 days after the last cycle of therapy |
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