Ovarian Cancer Clinical Trial
Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
Summary
This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, 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 bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.
Full Description
PRIMARY OBJECTIVES:
I. To determine if capecitabine and oxaliplatin reduces the death rate compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube.
II. To determine if bevacizumab reduces the death rate compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube.
SECONDARY OBJECTIVES:
I. To determine if capecitabine and oxaliplatin increases the duration of progression-free survival (PFS) compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube.
II. To determine if bevacizumab increases the duration of PFS compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube.
III. To compare the response rates for capecitabine and oxaliplatin versus carboplatin and paclitaxel in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery.
IV. To compare the response rates for bevacizumab versus no bevacizumab in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery.
V. To determine the nature and degree of toxicity of capecitabine and oxaliplatin compared with that of carboplatin and paclitaxel in this cohort of patients.
VI. To determine the nature and degree of toxicity of bevacizumab in this cohort of patients.
VII. To compare capecitabine and oxaliplatin versus carboplatin and paclitaxel with respect to changes in patient reported neurotoxicity.
VIII. To determine the impact on quality of life (QOL, as measured by the Functional Assessment of Cancer Therapy-Ovarian [FACT-O] Trial Outcome Index [TOI]) following treatment with the above regimens.
TERTIARY OBJECTIVES:
I. To collect fixed and/or frozen tissue and whole blood for future research studies.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive carboplatin intravenously (IV) over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
ARM III: Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
ARM IV: Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
Eligibility Criteria
Inclusion Criteria:
Patients with a histologic diagnosis of mucinous adenocarcinoma of the ovary or fallopian tube with either optimal (=< 1 cm residual disease) or suboptimal residual disease following initial surgery; patients may have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or no measurable disease
All patients must have had appropriate surgery including appendectomy (unless patient has history of prior appendectomy) for ovarian or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
Patients must have stage II-IV disease (new or recurrent-chemonaïve; no brain metastasis) or recurrent stage I disease (chemonaïve)
Newly diagnosed patients must begin protocol therapy within 10 weeks of primary debulking; for stage I recurrent patients (chemonaïve), they should begin protocol therapy within 14 days of randomization
Patients must have a negative colonoscopy within 1 year of enrolling in the study
Absolute neutrophil count (ANC) >= 1,500/mcl
White blood cell (WBC) count >= 3,000/mcl
Platelets >= 100,000/mcl
Hemoglobin (Hgb) >= 10 g/dl (can be post transfusion)
Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN) OR creatinine clearance > 50 cc/min
Bilirubin =< 1.5 x ULN
Serum glutamic oxaloacetic transaminase (SGOT) =< to 2.5 x ULN
Alkaline phosphatase =< to 2.5 x ULN
Neuropathy (sensory and motor) =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Urine dipstick for proteinuria < 2+; if urine dipstick is >= 2+, 24 hour urine must demonstrate =< 1 g protein in 24 hours OR patients must have a urine protein-to-creatinine ratio (UPCR) < 1.0 mg/dL
Prothrombin time (PT) =< 1.5 x ULN
Activated prothrombin time (APTT) =< 1.5 x ULN
Patients of childbearing potential must agree to practice an effective form of birth control during study treatment and for six months after completion of treatment
Patients who have met the pre-entry requirements
Patients must have signed an approved informed consent and authorization permitting release of personal health information
Patients with Gynecologic Oncology Group (GOG) performance grade of 0, 1 or 2
Patients with life expectancy > 3 months
Exclusion Criteria:
Patients with known colon cancer or history of colon cancer
Patients with primary peritoneal carcinoma
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
Patients who have received chemotherapy, radiotherapy or any investigational treatment for a gynecologic cancer (does include breast cancer) or colorectal cancer prior to enrollment
Patients with a major surgical procedure anticipated during the course of the study; this includes but is not limited to: abdominal surgery (laparotomy or laparoscopy) such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery; please consult with the study chair prior to patient entry for any questions related to the classification of surgical procedures
Patients may have minor surgical procedures (i.e., mediport insertion) fine needle aspiration or core biopsies as long as it is performed > 7 days prior to the first date of bevacizumab therapy and there is no evidence of wound disruption or impaired healing
Patients with surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for fact that bevacizumab can be omitted from first cycle of chemotherapy)
Patients with a history of abdominal fistula or perforation within the past 12 months
Patients with a current, serious, non-healing wound, ulcer, or bone fracture; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
Patients with known hypersensitivity to Chinese hamster cell products or other recombinant human or humanized antibodies
Patients with mixed epithelial ovarian cancer histology
Patients with tumors of low malignant potential
History or evidence of upon physical examination of central nervous system (CNS) disease, including history of primary brain tumor or any history of brain metastases, or seizures not controlled with standard medical therapy
Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 100 mm Hg; patients with a history of hypertension are permitted
Myocardial infarction or unstable angina within 12 months of the first date of bevacizumab therapy
New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; women who have received prior treatment with anthracycline (including doxorubicin and/or liposomal doxorubicin) and have an ejection fraction < 50% will be excluded from the study
Grade 1, category 2 or greater, peripheral vascular disease; patient cannot have anything worse than mild, symptomatic claudication with exercise
History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of bevacizumab therapy
History of pulmonary embolism or deep vein thrombosis in the past 6 months
Previous history of malabsorption or other conditions preventing oral treatment
Patients who are pregnant or nursing
Patients with acute hepatitis or active infection that requires parenteral antibiotics
Patients with active bleeding or pathologic conditions that carry a high risk of bleeding such as a known bleeding disorder, coagulopathy or tumor involving the major vessels
Patients taking warfarin
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There are 207 Locations for this study
Birmingham Alabama, 35233, United States
Mobile Alabama, 36688, United States
Phoenix Arizona, 85013, United States
Jonesboro Arkansas, 72401, United States
Burbank California, 91505, United States
Castro Valley California, 94546, United States
Castro Valley California, 94546, United States
Emeryville California, 94608, United States
Emeryville California, 94608, United States
Fremont California, 94538, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Martinez California, 94553, United States
Mountain View California, 94040, United States
Oakland California, 94602, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Orange California, 92868, United States
San Pablo California, 94806, United States
Sylmar California, 91342, United States
Aurora Colorado, 80012, United States
Aurora Colorado, 80045, United States
Boulder Colorado, 80301, United States
Colorado Springs Colorado, 80907, United States
Denver Colorado, 80210, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80220, United States
Denver Colorado, 80222, United States
Englewood Colorado, 80113, United States
Fort Collins Colorado, 80524, United States
Grand Junction Colorado, 81501, United States
Greeley Colorado, 80631, United States
Lakewood Colorado, 80228, United States
Littleton Colorado, 80122, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80501, United States
Loveland Colorado, 80539, United States
Parker Colorado, 80138, United States
Pueblo Colorado, 81004, United States
Thornton Colorado, 80229, United States
Wheat Ridge Colorado, 80033, United States
Hartford Connecticut, 06102, United States
New Britain Connecticut, 06050, United States
Stamford Connecticut, 06904, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19718, United States
Gainesville Florida, 32610, United States
Orlando Florida, 32803, United States
Augusta Georgia, 30912, United States
Columbus Georgia, 31904, United States
Gainesville Georgia, 30501, United States
Savannah Georgia, 31405, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96826, United States
Bloomington Illinois, 61701, United States
Bloomington Illinois, 61704, United States
Canton Illinois, 61520, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Carthage Illinois, 62321, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Eureka Illinois, 61530, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Havana Illinois, 62644, United States
Hinsdale Illinois, 60521, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Macomb Illinois, 61455, United States
Monmouth Illinois, 61462, United States
Monmouth Illinois, 61462, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Princeton Illinois, 61356, United States
Rockford Illinois, 61104, United States
Spring Valley Illinois, 61362, United States
Elkhart Indiana, 46514, United States
Elkhart Indiana, 46514, United States
Elkhart Indiana, 46515, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46260, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Mishawaka Indiana, 46545, United States
Mishawaka Indiana, 46545, United States
Mishawaka Indiana, 46545, United States
Plymouth Indiana, 46563, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
South Bend Indiana, 46628, United States
Westville Indiana, 46391, United States
Clive Iowa, 50325, United States
Clive Iowa, 50325, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51102, United States
Sioux City Iowa, 51104, United States
West Des Moines Iowa, 50266, United States
West Des Moines Iowa, 50266, United States
Edgewood Kentucky, 41017, United States
Lexington Kentucky, 40536, United States
Pikeville Kentucky, 41501, United States
Lafayette Louisiana, 70503, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21204, United States
Bethesda Maryland, 20889, United States
Elkton Maryland, 21921, United States
Springfield Massachusetts, 01199, United States
Escanaba Michigan, 49829, United States
Iron Mountain Michigan, 49801, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49048, United States
Niles Michigan, 49120, United States
Saint Joseph Michigan, 49085, United States
Saint Joseph Michigan, 49085, United States
Jackson Mississippi, 39216, United States
Cape Girardeau Missouri, 63703, United States
Jefferson City Missouri, 65109, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63131, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59102, United States
Billings Montana, 59102, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Havre Montana, 59501, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59802, United States
Missoula Montana, 59802, United States
Omaha Nebraska, 68114, United States
Las Vegas Nevada, 89106, United States
Camden New Jersey, 08103, United States
Mount Holly New Jersey, 08060, United States
Voorhees New Jersey, 08043, United States
Albuquerque New Mexico, 87102, United States
Albuquerque New Mexico, 87106, United States
Stony Brook New York, 11794, United States
Syracuse New York, 13210, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27710, United States
Goldsboro North Carolina, 27534, United States
Hendersonville North Carolina, 28792, United States
Winston-Salem North Carolina, 27104, United States
Winston-Salem North Carolina, 27157, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Akron Ohio, 44304, United States
Bellefontaine Ohio, 43311, United States
Canton Ohio, 44710, United States
Chillicothe Ohio, 45601, United States
Cincinnati Ohio, 45219, United States
Cincinnati Ohio, 45220, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43213, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43219, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Delaware Ohio, 43015, United States
Kettering Ohio, 45429, United States
Lancaster Ohio, 43130, United States
Marietta Ohio, 45750, United States
Mayfield Heights Ohio, 44124, United States
Mentor Ohio, 44060, United States
Mount Vernon Ohio, 43050, United States
Newark Ohio, 43055, United States
Portsmouth Ohio, 45662, United States
Springfield Ohio, 45505, United States
Westerville Ohio, 43081, United States
Zanesville Ohio, 43701, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Abington Pennsylvania, 19001, United States
Bethlehem Pennsylvania, 18015, United States
Danville Pennsylvania, 17822, United States
Hazleton Pennsylvania, 18201, United States
Pittsburgh Pennsylvania, 15232, United States
State College Pennsylvania, 16801, United States
Wilkes-Barre Pennsylvania, 18711, United States
Providence Rhode Island, 02905, United States
Anderson South Carolina, 29621, United States
Anderson South Carolina, 29621, United States
Greenville South Carolina, 29601, United States
Spartanburg South Carolina, 29303, United States
Sioux Falls South Dakota, 57104, United States
Sioux Falls South Dakota, 57117, United States
Knoxville Tennessee, 37920, United States
Dallas Texas, 75235, United States
Dallas Texas, 75390, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Danville Virginia, 24541, United States
Fredericksburg Virginia, 22408, United States
Lynchburg Virginia, 24501, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
La Crosse Wisconsin, 54601, United States
Manitowoc Wisconsin, 54221, United States
Marinette Wisconsin, 54143, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53233, United States
Oconto Falls Wisconsin, 54154, United States
Sheboygan Wisconsin, 53081, United States
Sturgeon Bay Wisconsin, 54235, United States
Summit Wisconsin, 53066, United States
West Allis Wisconsin, 53227, United States
Casper Wyoming, 82609, United States
Sheridan Wyoming, 82801, United States
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