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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

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ClinicalTrials.gov Identifier: NCT00811408
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : December 19, 2008
Last Update Posted : January 28, 2010
Sponsor:
Information provided by:

December 18, 2008
December 19, 2008
January 28, 2010
April 2008
October 2009   (Final data collection date for primary outcome measure)
Maximum tolerated dose of cidofovir
Same as current
Complete list of historical versions of study NCT00811408 on ClinicalTrials.gov Archive Site
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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
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

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
  • Cervical Cancer
  • Precancerous Condition
  • Drug: carboplatin
  • Drug: cidofovir
  • Genetic: protein expression analysis
  • Other: laboratory biomarker analysis
  • Radiation: brachytherapy
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
24
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October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00811408
CDR0000626799
IGR-CSET-2007/1297
IGR-HPV-RX
INCA-RECF-0813
EUDRACT-2007-005505-21
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Gustave Roussy, Cancer Campus, Grand Paris
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Investigator: Eric Deutsch, MD Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP