Cervical Cancer
Conditions
Keywords
stage III cervical cancer, stage IV cervical cancer, recurrent cervical cancer, cervical squamous cell carcinoma
Brief summary
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 DX-8951f in treating women who have advanced or recurrent cancer of the cervix.
Detailed description
OBJECTIVES: * Determine the antitumor activity of DX-8951f in women with advanced or recurrent squamous cell carcinoma of the cervix. * Evaluate the quantitative and qualitative toxic effects of this regimen in these patients. * Evaluate the pharmacokinetics of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until death. PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.
Interventions
Sponsors
Daiichi Sankyo
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed advanced or recurrent squamous cell carcinoma of the cervix not curable by surgery or radiotherapy * Measurable disease * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No active congestive heart failure * No uncontrolled angina * No myocardial infarction within the past 6 months Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent serious infection * No other malignancy within the past 5 years except nonmelanomatous skin cancer * No other life threatening illness * No psychosis, mental disability, or incompetence PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biologic therapy Chemotherapy: * At least 4 weeks since prior chemotherapy * No more than 1 prior chemotherapy regimen (except chemotherapy for radiosensitization) * No prior camptothecin * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * At least 4 weeks since prior surgery * No concurrent surgery Other: * At least 4 weeks since other prior investigational drugs (including analgesics or antiemetics) * No other concurrent investigational drugs during or within 28 days after final dose of study drug * No concurrent drugs that induce or inhibit CYP3A enzyme
Countries
United States
Outcome results
None listed