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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 because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00811408
First received: December 18, 2008
Last updated: January 27, 2010
Last verified: July 2009
History of Changes
  Purpose

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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Maximum tolerated dose of cidofovir [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811408

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, F-94805
Contact: Eric Deutsch, MD     33-1-4211-4339        
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Investigator: Eric Deutsch, MD Institut Gustave Roussy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00811408     History of Changes
Other Study ID Numbers: CDR0000626799, IGR-CSET-2007/1297, IGR-HPV-RX, INCA-RECF-0813, EUDRACT-2007-005505-21
Study First Received: December 18, 2008
Last Updated: January 27, 2010
Health Authority: Unspecified

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 Diseases
Uterine Cervical Neoplasms
Precancerous Conditions
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Cidofovir
 Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on May 23, 2013