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Cidofovir in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Receiving Chemotherapy and Radiation Therapy
Conditions
Cervical Cancer - Precancerous Condition
Conditions: official terms
Precancerous Conditions - Uterine Cervical Neoplasms
Conditions: 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 Type
Interventional
Study Phase
Phase 1
Study Design
Primary Purpose: Treatment
Intervention
Name: carboplatin
Type: Drug
Name: cidofovir
Type: Drug
Name: protein expression analysis
Type: Genetic
Name: laboratory biomarker analysis
Type: Other
Name: brachytherapy
Type: Radiation
Name: radiation therapy
Type: Radiation
Overall Status
Recruiting
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.
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
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
- 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
Location
Institut Gustave Roussy
Villejuif, France
Status: Recruiting
Contact: Eric Deutsch, MD - 33-1-4211-4339
Start Date
April 2008
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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