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Trial record 8 of 8 for:    "Cervical Adenocarcinoma" | "Carboplatin"

Cidofovir in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Receiving Chemotherapy and Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Study Start Date : April 2008
Estimated Primary Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
Drug Information available for: Cidofovir

Primary Outcome Measures :
  1. Maximum tolerated dose of cidofovir

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00811408

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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
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OverallOfficial: Eric Deutsch, MD Gustave Roussy, Cancer Campus, Grand Paris

Layout table for additonal information Identifier: NCT00811408     History of Changes
Other Study ID Numbers: CDR0000626799
First Posted: December 19, 2008    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: July 2009

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:
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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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action