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A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865, IND #113912) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients With Mucinous Epithelial Ovarian Cancer or Fallopian Tube Cancer (MEOC)

Phase 3
18 Years
Open (Enrolling)
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

Thank you

Trial Information

A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865, IND #113912) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients With Mucinous Epithelial Ovarian Cancer or Fallopian Tube Cancer (MEOC)


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

II. To determine if bevacizumabreduces the death rate compared to no bevacizumab in women
with mucinous adenocarcinoma of the ovary or fallopian tube.


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

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.


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

Inclusion Criteria:

- Histologically confirmed mucinous carcinoma of the ovary or fallopian tube

- Cytological (e.g., fine-needle aspiration) examination is inadequate for

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

Examined using Kaplan-Meier curves.

Outcome Time Frame:

Up to 7 years

Safety Issue:


Principal Investigator

David Gershenson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

January 2010

Completion Date:

Related Keywords:

  • 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
  • Cystadenocarcinoma
  • Cystadenoma
  • Cystadenoma, Mucinous
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Cystadenocarcinoma, Mucinous
  • Neoplasms, Glandular and Epithelial



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