Cidofovir in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Receiving Chemotherapy and Radiation Therapy

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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 uses high-energy x-rays to kill tumor cells. Drugs such as cidofovir may make tumor cells more sensitive to radiation therapy. Giving cidofovir together with radiation therapy and chemotherapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of cidofovir in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer who are receiving chemotherapy together with radiation therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Carboplatin; Cidofovir

Criteria

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