Purpose:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who
have persistent or recurrent cancer of the cervix.
Study summary:
OBJECTIVES:
- Determine the antitumor activity of gemcitabine in patients with persistent or
recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment
protocols.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4
weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 15-37 patients will be accrued for this study within 1
year.
Criteria:
DISEASE CHARACTERISTICS:
- Diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that
has failed local therapeutic measures and is considered incurable
- Eligible subtypes:
- Adenocarcinoma
- Adenosquamous carcinoma
- Undifferentiated carcinoma
- Must have documented disease progression
- Histologic confirmation of original primary tumor required
- Bidimensionally measurable disease
- Ineligible for higher priority GOG protocol
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least 100,000/mm^3
- Granulocyte count at least 1,500/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT and alkaline phosphatase no greater than 3 times normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Other:
- No significant infection
- Not pregnant
- Fertile patients must use effective contraception
- No other invasive malignancy within the past 5 years except nonmelanomatous skin
cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent filgrastim (G-CSF)
Chemotherapy:
- No prior gemcitabine
- At least 3 weeks since other prior chemotherapy for cervical cancer and recovered
- No more than 1 prior chemotherapy regimen (single or combination cytotoxic therapy)
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 3 weeks since prior radiotherapy for cervical cancer and recovered
Surgery:
- At least 3 weeks since prior surgery for cervical cancer and recovered
Other:
- No prior cancer treatment that would preclude study