Modulating the Expression of Oncoproteins of Papillomavirus (HPV) to Increase Radiosensitivity: a Phase I Study of Antiviral Agent Cidofovir and Chemoradiotherapy Therapy in Cervical Cancers
18 Years
70 Years
Female
Cervical Cancer, Precancerous Condition
Trial Information
Modulating the Expression of Oncoproteins of Papillomavirus (HPV) to Increase Radiosensitivity: a Phase I Study of Antiviral Agent Cidofovir and Chemoradiotherapy Therapy in Cervical Cancers
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of cidofovir
Safety Issue:
Yes
Principal Investigator
Eric Deutsch, MD
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
Unspecified
Study ID:
CDR0000626799
NCT ID:
NCT00811408
Start Date:
April 2008
Completion Date:
Related Keywords:
- Cervical Cancer
- Precancerous Condition
- 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
- Uterine Cervical Neoplasms
- Precancerous Conditions
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