Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy
A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy
  • Phase

    Phase 3
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if carboplatin is more effective with or without gemcitabine for ovarian epithelial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with or without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has not responded to previous chemotherapy.

Compare time to progression in patients with advanced ovarian epithelial carcinoma who failed prior first-line platinum-based therapy when treated with carboplatin with or without gemcitabine.
Compare response rate, duration of response, and survival time of patients treated with these regimens.
Compare the toxicity of these treatment regimens in these patients.
Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to progression-free time (6-12 months vs more than 12 months), type of prior first-line therapy, and bidimensionally measurable disease (yes vs no). Patients are randomized to one of two treatment arms.

Arm I: Patients receive carboplatin IV over 30-60 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.
Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats every 3 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each subsequent chemotherapy course, and at 50 days after study.

Patients are followed at 50 days, every 2 months for 1 year, and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
Study Started
Sep 30
Primary Completion
Oct 31
Study Completion
Oct 31
Last Update
Dec 23

Drug carboplatin

Drug gemcitabine hydrochloride



Histologically confirmed ovarian epithelial carcinoma not amenable to curative surgery or radiotherapy

Evidence of recurrence or progression 6 months after discontinuation of prior first-line platinum-containing regimen
No tumor of borderline malignancy
Evaluable disease outside previously irradiated area
No CNS metastases



18 and over

Performance status:

ECOG 0-2

Life expectancy:

At least 12 weeks


Neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3


Not specified


Glomerular filtration rate greater than 50 mL/min


No concurrent active infection
No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
No other concurrent serious systemic disorder


Biologic therapy:

Not specified


See Disease Characteristics
No more than 1 prior platinum-based chemotherapy regimen
No prior gemcitabine
No other concurrent cytotoxic or antineoplastic treatment

Endocrine therapy:

At least 3 weeks since prior hormonal therapy
Concurrent hormone replacement therapy allowed
Concurrent steroid antiemetics allowed


See Disease Characteristics
At least 3 weeks since prior radiotherapy (limited to the small pelvis)
Concurrent palliative radiotherapy to nontarget lesions allowed


See Disease Characteristics


At least 3 weeks since other prior investigational agents
No Results Posted