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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT00428194
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cisplatin — DRUG
    40 mg/m\^2 every 7 days during radiation
  • erlotinib hydrochloride — DRUG
    Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m\^2 by mouth once a day beginning day 1.
  • radiation therapy — PROCEDURE
    standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)

Study Details

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.

Key Dates

First listed
Jan 29, 2007
Start date
Jan 31, 2007
Status verified
Nov 2017
Primary completion
Mar 31, 2008
Completion
Mar 31, 2008

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Erlotinib 100 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m\^2 intravenous every 7 days during RT) and continuing daily through radiation
  • Experimental: Cohort 2
    Erlotinib 125 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m\^2 intravenous every 7 days during RT) and continuing daily through radiation
  • Active Comparator: Cohort 3
    Erlotinib 150 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m\^2 intravenous every 7 days during RT) and continuing daily through radiation

Primary Outcome Measure

Maximum tolerated dose of erlotinib hydrochloride [ Time Frame: Day 14 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Minnesota Cancer CenterMinneapolisMinnesota55455-

Find similar trials in Minneapolis, MN

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Minnesota Cancer Center· Minneapolis, MN

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