Cidofovir in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Receiving Chemotherapy and Radiation Therapy
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cervical Cancer; Precancerous Condition
Intervention: carboplatin (Drug); cidofovir (Drug); protein expression analysis (Genetic); laboratory biomarker analysis (Other); brachytherapy (Radiation); radiation therapy (Radiation)
Phase: Phase 1
Sponsored by: Institut Gustave Roussy
Official(s) and/or principal investigator(s):
Eric Deutsch, MD, Affiliation: Institut Gustave Roussy
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.
Official title: 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
Study design: Primary Purpose: Treatment
Primary outcome: Maximum tolerated dose of cidofovir
- Determine the maximum tolerated dose of cidofovir when given as a radiosensitizer in
patients with stage IB-IVA cervical cancer undergoing concurrent chemoradiotherapy.
- 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.
Minimum age: 18 Years.
Maximum age: 70 Years.
- 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
- 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
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy
- More than 30 days since prior experimental drugs
Locations and Contacts
Institut Gustave Roussy, Villejuif F-94805, France; Recruiting
Eric Deutsch, MD, Phone: 33-1-4211-4339
Starting date: April 2008
Last updated: January 27, 2010