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

This study has suspended participant recruitment.
(Temporarily Closed to Accrual)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01081262
First received: March 4, 2010
Last updated: July 1, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Mucinous Cystadenocarcinoma
Ovarian Mucinous Cystadenoma With Proliferating Activity
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Stage IA Fallopian Tube Cancer
Stage IA Ovarian Epithelial Cancer
Stage IB Fallopian Tube Cancer
Stage IB Ovarian Epithelial Cancer
Stage IC Fallopian Tube Cancer
Stage IC Ovarian Epithelial Cancer
Stage IIA Fallopian Tube Cancer
Stage IIA Ovarian Epithelial Cancer
Stage IIB Fallopian Tube Cancer
Stage IIB Ovarian Epithelial Cancer
Stage IIC Fallopian Tube Cancer
Stage IIC Ovarian Epithelial Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Epithelial Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Epithelial Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Epithelial Cancer
Other: quality-of-life assessment
Drug: carboplatin
Drug: paclitaxel
Drug: oxaliplatin
Drug: capecitabine
Biological: bevacizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients With Mucinous Epithelial Ovarian Cancer or Fallopian Tube Cancer (MEOC)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    Examined using Kaplan-Meier curves.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Response rates assessed by Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
    Compared among treatment arms by chi-square test.

  • Frequency and severity of adverse effects assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) [ Time Frame: Up to 7 years ] [ Designated as safety issue: Yes ]
  • Quality of life assessed by FACT-TOI, FACT-GOG/NTX-4, and EQ-5D [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 332
Study Start Date: October 2010
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Experimental: Arm II (oxaliplatin and capecitabine)
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.
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Drug: oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • L-OHP
Drug: capecitabine
Given orally
Other Names:
  • CAPE
  • Ro 09-1978/000
  • Xeloda
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.
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF
Experimental: Arm IV (oxaliplatin, capecitabine, bevacizumab)
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Drug: oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • L-OHP
Drug: capecitabine
Given orally
Other Names:
  • CAPE
  • Ro 09-1978/000
  • Xeloda
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081262

  Show 249 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: David Gershenson Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01081262     History of Changes
Other Study ID Numbers: NCI-2011-02516, NCI-2011-02516, CDR0000667089, GOG-0241, GOG-0241, U10CA027469
Study First Received: March 4, 2010
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystadenocarcinoma
Cystadenoma
Cystadenoma, Mucinous
Ovarian Neoplasms
Fallopian Tube Neoplasms
Cystadenocarcinoma, Mucinous
Neoplasms, Glandular and Epithelial
Adenocarcinoma
Carcinoma
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Adenoma
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Antibodies
Antibodies, Monoclonal
Fluorouracil
Oxaliplatin
Capecitabine
Bevacizumab
Carboplatin

ClinicalTrials.gov processed this record on August 18, 2014