Status:
TERMINATED
Docetaxel and Carboplatin in Treating Patients With Recurrent Stage IVB Squamous Cell Carcinoma (Cancer) of the Cervix
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining docetaxel with carboplatin may...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of docetaxel when administered with carboplatin in patients with recurrent stage IVB squamous cell carcinoma of the cervix. * Determine the...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the uterine cervix
- Advanced disease (stage IVB)
- Persistent or recurrent disease
- No available curative treatment options
- Measurable disease by physical examination, chest x-ray, CT scan, or MRI
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- GOG 0-2
- Life expectancy
- More than 6 months
- Hematopoietic
- Absolute neutrophil count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin \> 8 g/dL
- Hepatic
- Bilirubin normal
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal OR
- Alkaline phosphatase ≤ 4 times ULN AND SGOT and SGPT normal
- Renal
- Creatinine \< 1.5 times ULN
- Other
- No other invasive malignancy within the past 5 years
- No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No peripheral neuropathy \> grade 1
- No other concurrent malignancy except curatively treated non-melanoma skin cancer
- No other serious medical or psychiatric illness that would preclude giving informed consent or limit survival
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent biologic therapy
- Chemotherapy
- No more than 2 prior chemotherapy regimens
- One sensitizing chemotherapy regimen during radiotherapy AND 1 regimen for recurrent disease are considered 2 regimens
- At least 4 weeks since prior chemotherapy
- No prior docetaxel
- No prior carboplatin
- No other concurrent chemotherapy
- Endocrine therapy
- At least 4 weeks since prior hormonal therapy
- Radiotherapy
- See Chemotherapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
- Surgery
- At least 3 weeks since prior major surgery
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00084890
Start Date
November 1 2003
End Date
April 1 2010
Last Update
August 10 2018
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1065