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Keep this study
Lead
Gynecologic Oncology Group
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix
