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Home > "D" Clinical Trials Conditions > DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix  DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix
DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix
For Condition: recurrent cervical cancer,stage 4 cervical cancer,stage 3 cervical cancer,cervical squamous cell carcinoma
Status: Suspended
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertDeJager, Study Chair, Daiichi Pharmaceuticals
St. Luke's-Roosevelt Hospital
New York City, New York, 10019
United States
Albert Einstein Clinical Cancer Center
Bronx, New York, 10461
United States
Texas Oncology PA (TOPA) at Baylor-Sammons
Dallas, Texas, 75246
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Ruppert Health Center
Toledo, Ohio, 43614
United States
Additional Information:
Study ID Numbers: CDR0000067525; DAIICHI-8951A-PRT015,MDA-DM-99247
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004866
Other Stage 3 Cervical Cancer Studies:
1. Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
2. Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
3. EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer
4. DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix
5. Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix
Related Studies:
Other stage 3 cervical cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix
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