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Clinical Trials (PDQ®)

Clinical Trials (PDQ®)

Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine, With or Without Bevacizumab, as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II, Stage III, Stage IV, or Recurrent Stage I Epithelial Ovarian Cancer or Fallopian Tube Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIHealth services research, TreatmentTemporarily closed18 and overNCINCI-2011-02516
CDR0000667089, GOG-0241, U10CA027469, UCL-07/095, UCL-mEOC, ISRCTN83438782, EUDRACT-2008-000837-23, EU-21007, NCRI-UCL-07/095, CRUK-UCL-07/095, NCT01081262

Trial Description

Summary

This randomized phase III trial is studying 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, stage III, stage IV, or recurrent stage I epithelial ovarian cancer 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, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. 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.

Further Study Information

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 bevacizumabreduces 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 FACT-O 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: This is a multicenter study. Patients are stratified according to disease status (no gross residual disease [i.e., 0] vs residual disease [> 0]), disease stage (recurrent stage I [chemonaive] vs stage II-IV), and country (U.S. vs non-U.S.). Patients are randomized to 1 of 4 treatment arms.

ARM I: 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.

ARM II: Patients receive oxaliplatin IV over 2-6 hours on day 1 and oral capecitabine twice a day 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.

Patients complete quality-of-life questionnaires (FACT-O TOI, FACT/GOG-NTX Subscale, and EQ-5D) at baseline, during study treatment, and after completion of study treatment.

After completion of study treatment, patients are followed at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3-5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Eligibility Criteria

Inclusion Criteria:

  • Histologically confirmed mucinous carcinoma of the ovary or fallopian tube
  • Cytological (e.g., fine-needle aspiration) examination is inadequate for diagnosis
  • No epithelial non-mucinous cell types
  • Meets 1 of the following staging criteria:
  • FIGO stage II-IV disease
  • Recurrent stage I disease (chemonaïve)
  • Patients must have a negative colonoscopy within 1 year before study entry
  • No primary peritoneal carcinoma
  • No epithelial ovarian tumors of low malignant potential
  • No known brain metastases
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • WBC ≥ 3 x 10^9/L
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Hemoglobin ≥ 10 g/dL (may be post-transfusion)
  • Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Serum transaminases ≤ 2.5 x ULN
  • Serum creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 50 mL/min
  • Urine dipstick for proteinuria < 2+ OR 24-hour urine protein ≤ 1 g
  • INR ≤ 1.5 x ULN
  • APTT ≤ 1.5 x ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Adequate neurological function (sensory and motor neuropathy ≤ grade 1)
  • No prior or concurrent peripheral neuropathy
  • No evidence of upper GI cancer (e.g., pancreatic cancer) on CT or MRI scan
  • No history of another malignancy except carcinoma in situ of the cervix or basal cell carcinoma of the skin
  • No medical or psychiatric conditions that compromise the patient's ability to give informed consent
  • No clinically significant cardiac disease, symptomatic coronary artery disease, or congestive heart failure
  • No peripheral vascular disease ≥ grade 3 (i.e., symptomatic and interfering with activities of daily living requiring repair or revision), cardiac arrhythmia, or myocardial infarction within the past 12 months
  • No known hypersensitivity to bevacizumab and its excipients or to chemotherapy (including cremophor)
  • No history of malabsorption or other conditions preventing oral treatment
  • No nonhealing wound, ulcer, or bone fracture (patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible provided they undergo three weekly wound examinations)
  • No history or evidence of thrombotic or hemorrhagic disorders
  • No uncontrolled hypertension (sustained elevation of BP > 150/100 mmHg despite antihypertensive therapy)
  • No significant traumatic injury within the past 4 weeks
  • No cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
  • No other concurrent uncontrolled medical conditions
  • No prior chemotherapy
  • No prior radiotherapy or investigational treatment for ovarian or rectal cancer
  • No prior mouse CA125 antibody
  • At least 10 days since prior and no concurrent chronic use of aspirin (> 325 mg/day)
  • Prophylactic low-dose aspirin (≤ 325 mg/day) in patients who are at risk of an arterial thromboembolic event allowed
  • At least 4 weeks since prior surgery or open biopsy and no planned surgery during the 58-week period from the start of study treatment
  • No second-look surgery

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

David GershensonPrincipal Investigator

Trial Sites

U.S.A.
California
  Sylmar
 Olive View - UCLA Medical Center Foundation
 Christine Holschneider Ph: 888-798-0719
Illinois
  Bloomington
 Illinois CancerCare - Bloomington
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 St. Joseph Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Canton
 Illinois CancerCare - Canton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Carthage
 Illinois CancerCare - Carthage
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Eureka
 Illinois CancerCare - Eureka
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Galesburg
 Galesburg Clinic, PC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Kewanee
 Illinois CancerCare - Kewanee Clinic
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Macomb
 Illinois CancerCare - Macomb
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Monmouth
 Illinois CancerCare - Monmouth
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF Holy Family Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Normal
 Community Cancer Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Ottawa
 Community Hospital of Ottawa
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Ottawa
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Pekin
 Cancer Treatment Center at Pekin Hospital
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Pekin
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peoria
 CCOP - Illinois Oncology Research Association
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Peoria
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Methodist Medical Center of Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF St. Francis Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Proctor Hospital
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peru
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois Valley Community Hospital
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Princeton
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
Massachusetts
  Springfield
 Baystate Medical Center
 Tashanna K Myers Ph: 413-794-3565
  Email: tamara.wrenn@baystatehealth.org
North Dakota
  Bismarck
 Bismarck Cancer Center
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
South Carolina
  Anderson
 AnMed Cancer Center
 David Griffin Ph: 864-512-1000
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Maria C. Bell Ph: 218-333-5000
 Maria C. Bell Ph: 218-333-5000

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01081262
ClinicalTrials.gov processed this data on September 25, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.