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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: December 18, 2008
Last updated: January 27, 2010
Last verified: July 2009

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.

Condition Intervention Phase
Cervical Cancer
Precancerous Condition
Drug: carboplatin
Drug: cidofovir
Genetic: protein expression analysis
Other: laboratory biomarker analysis
Radiation: brachytherapy
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose of cidofovir

Estimated Enrollment: 24
Study Start Date: April 2008
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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 clinical monitoring


  • No prior radiotherapy or chemotherapy
  • More than 30 days since prior experimental drugs
  Contacts and Locations
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Please refer to this study by its identifier: NCT00811408

Institut Gustave Roussy Recruiting
Villejuif, France, F-94805
Contact: Eric Deutsch, MD    33-1-4211-4339      
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
OverallOfficial: Eric Deutsch, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information Identifier: NCT00811408     History of Changes
Other Study ID Numbers: CDR0000626799
Study First Received: December 18, 2008
Last Updated: January 27, 2010

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Precancerous Conditions
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents processed this record on April 26, 2017