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Clinical Trials/NCT00428194
NCT00428194WithdrawnPhase 1

Erlotinib in Combination With Cisplatin as Radiosensitizing Agents in Women Receiving Radiation Therapy for Locally Advanced Squamous Cell Carcinoma of the Cervix; A Phase I Trial

Masonic Cancer Center, University of Minnesota1 site in 1 countryStarted: January 2007Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Withdrawn
Locations
1
Primary Endpoint
Maximum tolerated dose of erlotinib hydrochloride

Study Overview

Brief 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.

Detailed Description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of erlotinib hydrochloride when administered with cisplatin and pelvic radiotherapy in patients with stage IB-IVA squamous cell carcinoma of the cervix.

Secondary

  • Determine the toxicity profile of this regimen.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of squamous cell carcinoma of the cervix
  • Stage IB-IVA disease
  • Scheduled to undergo standard radiotherapy and receive weekly cisplatin
  • ECOG performance status 0-2
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 1 week after completion of study treatment
  • Must be able to take oral medication

Exclusion Criteria

  • Malabsorption syndrome
  • Serious underlying medical condition that would impair the ability of patient to receive treatment
  • Known hypersensitivity to erlotinib hydrochloride
  • Psychological, familial, sociological, or geographical conditions that would preclude study compliance
  • Less than 21 days since prior nonapproved or investigational drugs
  • Prior chemotherapy
  • Prior radiotherapy
  • Prior anti-epidermal growth factor receptor treatment
  • Prior gastrointestinal surgery that limits absorption (i.e., requiring total parenteral nutrition)
  • Concurrent use of any of the following agents and therapies:
  • Other antineoplastic or antitumor agents
  • Other chemotherapy
  • Other investigational agents
  • Radiotherapy
  • Immunotherapy
  • Anticancer hormonal therapy

Arms & Interventions

Cohort 1

Experimental

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

Intervention: cisplatin (Drug)

Cohort 1

Experimental

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

Intervention: erlotinib hydrochloride (Drug)

Cohort 1

Experimental

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

Intervention: radiation therapy (Procedure)

Cohort 2

Experimental

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

Intervention: cisplatin (Drug)

Cohort 2

Experimental

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

Intervention: erlotinib hydrochloride (Drug)

Cohort 2

Experimental

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

Intervention: radiation therapy (Procedure)

Cohort 3

Active Comparator

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

Intervention: cisplatin (Drug)

Cohort 3

Active Comparator

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

Intervention: erlotinib hydrochloride (Drug)

Cohort 3

Active Comparator

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

Intervention: radiation therapy (Procedure)

Outcomes

Primary Outcomes

Maximum tolerated dose of erlotinib hydrochloride

Time Frame: Day 14

Secondary Outcomes

  • Toxicity(4-6 Weeks Post Last Study Dose)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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