NCT00811408

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Last Updated

January 28, 2010

Status Verified

July 1, 2009

Enrollment Period

1.5 years

First QC Date

December 18, 2008

Last Update Submit

January 27, 2010

Conditions

Cervical CancerPrecancerous Condition

Keywords

human papilloma virus infectioncervical squamous cell carcinomacervical adenocarcinomastage IB cervical cancerstage II cervical cancerstage III cervical cancerstage IVA cervical cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of cidofovir

Interventions

carboplatinDRUG
cidofovirDRUG
protein expression analysisGENETIC
laboratory biomarker analysisOTHER
brachytherapyRADIATION
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, F-94805, France

RECRUITING

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPrecancerous ConditionsPapillomavirus Infections

Interventions

CarboplatinCidofovirBrachytherapyRadiotherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsOrganophosphonatesOrganophosphorus CompoundsCytosinePyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Eric Deutsch, MD

    Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 19, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2009

Last Updated

January 28, 2010

Record last verified: 2009-07

Locations

FR(1)