Cervical Cancer, Precancerous Condition
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
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.
Interventions
DRUGcarboplatin
DRUGcidofovir
GENETICprotein expression analysis
OTHERlaboratory biomarker analysis
RADIATIONbrachytherapy
RADIATIONradiation therapy
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose of cidofovir | — |
Countries
France
Outcome results
None listed