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)

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