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

Conditions

• Borderline Ovarian Mucinous Tumor
• Ovarian Mucinous Cystadenocarcinoma
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Stage IA Fallopian Tube Cancer AJCC v6 and v7
• Stage IA Ovarian Cancer AJCC v6 and v7
• Stage IB Fallopian Tube Cancer AJCC v6 and v7
• Stage IB Ovarian Cancer AJCC v6 and v7
• Stage IC Fallopian Tube Cancer AJCC v6 and v7
• Stage IC Ovarian Cancer AJCC v6 and v7
• Stage IIA Fallopian Tube Cancer AJCC v6 and v7
• Stage IIA Ovarian Cancer AJCC V6 and v7
• Stage IIB Fallopian Tube Cancer AJCC v6 and v7
• Stage IIB Ovarian Cancer AJCC v6 and v7
• Stage IIC Fallopian Tube Cancer AJCC v6 and v7
• Stage IIC Ovarian Cancer AJCC v6 and v7
• Stage IIIA Fallopian Tube Cancer AJCC v7
• Stage IIIA Ovarian Cancer AJCC v6 and v7
• Stage IIIB Fallopian Tube Cancer AJCC v7
• Stage IIIB Ovarian Cancer AJCC v6 and v7
• Stage IIIC Fallopian Tube Cancer AJCC v7
• Stage IIIC Ovarian Cancer AJCC v6 and v7
• Stage IV Fallopian Tube Cancer AJCC v6 and v7
• Stage IV Ovarian Cancer AJCC v6 and v7

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Capecitabine — DRUG
  Given PO
• Carboplatin — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Oxaliplatin — DRUG
  Given IV
• Paclitaxel — DRUG
  Given IV
• Quality-of-Life Assessment — OTHER
  Ancillary studies

Study Details

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.

Key Dates

First listed

Mar 5, 2010

Start date

Oct 12, 2010

Status verified

Feb 2026

Primary completion

Feb 25, 2015

Completion

Mar 12, 2027

Study Design

Enrollment

50 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (carboplatin and paclitaxel)
  Patients receive carboplatin 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.
• Experimental: Arm II (oxaliplatin and capecitabine)
  Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm III (carboplatin, paclitaxel, bevacizumab)
  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.
• Experimental: Arm IV (oxaliplatin, capecitabine, bevacizumab)
  Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.

Primary Outcome Measure

Overall Survival [ Time Frame: Up to five years ]

Locations (248)

Find similar trials in Birmingham, AL

Related Studies

• Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF
  PHASE1 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers
  PHASE1 · Recruiting · M.D. Anderson Cancer Center · Baltimore, Maryland
• ONC201 Plus Weekly Paclitaxel in Patients With Platinum Refractory or Resistant Ovarian Cancer
  PHASE2 · Recruiting · Ira Winer · Detroit, Michigan
• Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
  PHASE1 · Recruiting · University of Utah · Salt Lake City, Utah