Status:
UNKNOWN
Cidofovir in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Receiving Chemotherapy and Radiation Therapy
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Cervical Cancer
Precancerous Condition
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy u...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of cidofovir when given as a radiosensitizer in patients with stage IB-IVA cervical cancer undergoing concurrent chemoradiotherapy. Second...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of squamous cell carcinoma or adenocarcinoma of the cervix
- Stage IB2 (\> 4 cm), II, III, or IVA disease
- No lumbo-aortic metastasis
- Initial tumor must be HPV-positive
- PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy \> 3 months
- ANC \> 2,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Transaminases \< 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase \< 1.5 times ULN
- Bilirubin \< 1.5 times ULN
- Creatinine \< 1.5 times ULN
- Creatinine clearance ≥ 55 mL/min
- Proteinuria \< 2 g/L
- Not pregnant
- Negative pregnancy test
- No renal disease
- No concurrent active infection
- No prior or concurrent psychiatric illness
- No history of cancer except for basal cell carcinoma
- No other active infection or serious illness that would prevent the patient from receiving study treatment
- No known psychological, familial, social, or geographic reason that would preclude clinical monitoring
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy
- More than 30 days since prior experimental drugs
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00811408
Start Date
April 1 2008
Last Update
January 28 2010
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, F-94805