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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 3
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

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


OBJECTIVES:

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

Hepatic:

- Not specified

Renal:

- Glomerular filtration rate greater than 50 mL/min

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- 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

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy (limited to the small pelvis)

- Concurrent palliative radiotherapy to nontarget lesions allowed

Surgery:

- See Disease Characteristics

Other:

- At least 3 weeks since other prior investigational agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jacobus Pfisterer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Schleswig-Holstein

Authority:

United States: Federal Government

Study ID:

CDR0000067993

NCT ID:

NCT00006453

Start Date:

September 1999

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

St. Mary's/Duluth Clinic Health SystemDuluth, Minnesota  55805