🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Mexico / NCT01081262
Active, not recruiting Phase 3

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

NCT01081262 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2010-10-12
Last updated
2026-08-28

Condition(s) studied

Borderline Ovarian Mucinous TumorOvarian Mucinous CystadenocarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaStage IA Fallopian Tube Cancer AJCC v6 and v7Stage IA Ovarian Cancer AJCC v6 and v7Stage IB Fallopian Tube Cancer AJCC v6 and v7Stage IB Ovarian Cancer AJCC v6 and v7Stage IC Fallopian Tube Cancer AJCC v6 and v7Stage IC Ovarian Cancer AJCC v6 and v7Stage IIA Fallopian Tube Cancer AJCC v6 and v7Stage IIA Ovarian Cancer AJCC V6 and v7Stage IIB Fallopian Tube Cancer AJCC v6 and v7Stage IIB Ovarian Cancer AJCC v6 and v7Stage IIC Fallopian Tube Cancer AJCC v6 and v7Stage IIC Ovarian Cancer AJCC v6 and v7Stage IIIA Fallopian Tube Cancer AJCC v7Stage IIIA Ovarian Cancer AJCC v6 and v7Stage IIIB Fallopian Tube Cancer AJCC v7Stage IIIB Ovarian Cancer AJCC v6 and v7Stage IIIC Fallopian Tube Cancer AJCC v7Stage IIIC Ovarian Cancer AJCC v6 and v7Stage IV Fallopian Tube Cancer AJCC v6 and v7Stage IV Ovarian Cancer AJCC v6 and v7

Investigational drug(s) / intervention(s)

Bevacizumab →Capecitabine →Carboplatin →Laboratory Biomarker AnalysisOxaliplatin →Paclitaxel →Quality-of-Life Assessment

Bevacizumab: Given IV

Capecitabine: Given PO

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (248)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama
University of South Alabama Mitchell Cancer Institute Mobile Alabama
Saint Joseph's Hospital and Medical Center Phoenix Arizona
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
East Bay Radiation Oncology Center Castro Valley California
Valley Medical Oncology Consultants-Castro Valley Castro Valley California
Bay Area Breast Surgeons Inc Emeryville California
Epic Care Partners in Cancer Care Emeryville California
Valley Medical Oncology Consultants-Fremont Fremont California
Los Angeles General Medical Center Los Angeles California
USC / Norris Comprehensive Cancer Center Los Angeles California
Contra Costa Regional Medical Center Martinez California
El Camino Hospital Mountain View California
Wilma Chan Highland Hospital Oakland California
Alta Bates Summit Medical Center - Summit Campus Oakland California
Bay Area Tumor Institute Oakland California
Hematology and Oncology Associates-Oakland Oakland California
Tom K Lee Inc Oakland California
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo California
Olive View-University of California Los Angeles Medical Center Sylmar California
The Medical Center of Aurora Aurora Colorado
UCHealth University of Colorado Hospital Aurora Colorado
Boulder Community Foothills Hospital Boulder Colorado
Penrose-Saint Francis Healthcare Colorado Springs Colorado
AdventHealth Porter Denver Colorado
Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
Saint Joseph Hospital - Cancer Centers of Colorado Denver Colorado
Rose Medical Center Denver Colorado
Western States Cancer Research NCORP Denver Colorado
Swedish Medical Center Englewood Colorado
Poudre Valley Hospital Fort Collins Colorado
Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
Banner North Colorado Medical Center Greeley Colorado
CommonSpirit Saint Anthony Hospital Cancer Center Lakewood Colorado
AdventHealth Littleton Littleton Colorado
Sky Ridge Medical Center Lone Tree Colorado
Longmont United Hospital Longmont Colorado
Banner North Colorado Medical Center - Loveland Campus Loveland Colorado

+ 208 more sites — see the full list on the official registry below.

On this site

📄 Avastin (bevacizumab) drug profile →

More National Cancer Institute (NCI) trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01081262 on ClinicalTrials.gov ↗ ← All trials in Mexico