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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

Primary Purpose

Cervical Cancer, Precancerous Condition

Status
Unknown status
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
carboplatin
cidofovir
protein expression analysis
laboratory biomarker analysis
brachytherapy
radiation therapy
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Gustave RoussyRecruiting

Outcomes

Primary Outcome Measures

Maximum tolerated dose of cidofovir

Secondary Outcome Measures

Full Information

First Posted
December 18, 2008
Last Updated
January 27, 2010
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00811408
Brief Title
Cidofovir in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Receiving Chemotherapy and 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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Precancerous Condition
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cidofovir
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Maximum tolerated dose of cidofovir

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Deutsch, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Deutsch, MD
Phone
33-1-4211-4339

12. IPD Sharing Statement

Learn more about this trial

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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