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: September 16, 2014
Last verified: June 2014

March 4, 2010
September 16, 2014
October 2010
July 2020   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
Examined using Kaplan-Meier curves.
Overall survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01081262 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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)

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    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
  • 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
  • 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.
    Interventions:
    • Other: quality-of-life assessment
    • Drug: carboplatin
    • Drug: paclitaxel
  • 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.
    Interventions:
    • Other: quality-of-life assessment
    • Drug: oxaliplatin
    • Drug: capecitabine
  • 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.
    Interventions:
    • Other: quality-of-life assessment
    • Drug: carboplatin
    • Drug: paclitaxel
    • Biological: bevacizumab
  • Experimental: Arm IV (oxaliplatin, capecitabine, bevacizumab)
    Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
    Interventions:
    • Other: quality-of-life assessment
    • Drug: oxaliplatin
    • Drug: capecitabine
    • Biological: bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
332
Not Provided
July 2020   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01081262
NCI-2011-02516, NCI-2011-02516, CDR0000667089, GOG-0241, GOG-0241, U10CA027469
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: David Gershenson Gynecologic Oncology Group
National Cancer Institute (NCI)
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP