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

NCT ID: NCT00811408

Last Updated: 2010-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30

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 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.

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.

Secondary

• Evaluate the influence of treatment on the expression of mRNA codons in HPV oncoproteins E6 and E7.
• Determine the rate of local control.

OUTLINE: This is a dose-escalation study of cidofovir.

Patients receive cidofovir IV weekly for 2 weeks prior to beginning radiotherapy and then once biweekly during radiotherapy. Patients undergo external pelvic radiotherapy for 5 weeks. Beginning ≤ 2 weeks later, patients undergo utero-vaginal brachytherapy. Some patients may also undergo a second course of external radiotherapy to the parametrium and/or lymph nodes ≤ 3 days after brachytherapy. Patients also receive concurrent carboplatin IV once weekly during external radiotherapy and brachytherapy.

Biological expression of HPV oncoproteins E6 and E7 is analyzed during treatment.

Conditions

Cervical Cancer; Precancerous Condition

Keywords

human papilloma virus infection; cervical squamous cell carcinoma; cervical adenocarcinoma; stage IB cervical cancer; stage II cervical cancer; stage III cervical cancer; stage IVA cervical cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

cidofovir

Intervention Type: DRUG

protein expression analysis

Intervention Type: GENETIC

laboratory biomarker analysis

Intervention Type: OTHER

brachytherapy

Intervention Type: RADIATION

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Principal Investigators

Eric Deutsch, MD

Role:

Gustave Roussy, Cancer Campus, Grand Paris

Locations

Institut Gustave Roussy

Villejuif, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Eric Deutsch, MD

Role: primary

Other Identifiers

IGR-CSET-2007/1297

Identifier Type: -

Identifier Source: secondary_id

IGR-HPV-RX

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF-0813

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2007-005505-21

Identifier Type: -

Identifier Source: secondary_id

CDR0000626799

Identifier Type: -

Identifier Source: org_study_id