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Erlotinib, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB-Stage IVA Cervical Cancer

NCT00428194 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-11-29

No results posted yet for this study

Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, 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. Erlotinib and cisplatin may make tumor cells more sensitive to radiation therapy. Giving erlotinib together with cisplatin and radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer.

Conditions

Interventions

DRUG

cisplatin

40 mg/m\^2 every 7 days during radiation

DRUG

erlotinib hydrochloride

Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m\^2 by mouth once a day beginning day 1.

PROCEDURE

radiation therapy

standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Levi S. Downs, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00428194 on ClinicalTrials.gov