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Trial Title:
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
Condition:
Cervical Cancer
Precancerous Condition
Conditions: Official terms:
Uterine Cervical Neoplasms
Precancerous Conditions
Cidofovir
Carboplatin
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
Overall status:
Unknown status
Study design:
Primary purpose:
Treatment
Intervention:
Intervention type:
Drug
Intervention name:
carboplatin
Intervention type:
Drug
Intervention name:
cidofovir
Intervention type:
Genetic
Intervention name:
protein expression analysis
Intervention type:
Other
Intervention name:
laboratory biomarker analysis
Intervention type:
Radiation
Intervention name:
brachytherapy
Intervention type:
Radiation
Intervention name:
radiation therapy
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
F-94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Eric Deutsch, MD
Phone:
33-1-4211-4339
Start date:
April 2008
Lead sponsor:
Agency:
Gustave Roussy, Cancer Campus, Grand Paris
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00811408