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

November 27, 2017 updated by: Masonic Cancer Center, University of Minnesota

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

OUTLINE: This is a multicenter, open-label, dose-escalation study of erlotinib hydrochloride.

Patients receive oral erlotinib hydrochloride once daily on days 1-35 and cisplatin IV on days 1, 8, 15, 22, and 29. Patients also undergo radiotherapy daily, 5 days a week, for approximately 5 weeks concurrently with chemotherapy.

Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose proceeding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed at 6 weeks.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: cisplatin
40 mg/m^2 every 7 days during radiation
Other Names:
  • CDDP
  • cisplatinum
Drug: erlotinib hydrochloride
Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m^2 by mouth once a day beginning day 1.
Other Names:
  • Tarceva(R)
Procedure: radiation therapy
standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
Other Names:
  • irradiation
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
Drug: cisplatin
40 mg/m^2 every 7 days during radiation
Other Names:
  • CDDP
  • cisplatinum
Drug: erlotinib hydrochloride
Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m^2 by mouth once a day beginning day 1.
Other Names:
  • Tarceva(R)
Procedure: radiation therapy
standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
Other Names:
  • irradiation
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
Drug: cisplatin
40 mg/m^2 every 7 days during radiation
Other Names:
  • CDDP
  • cisplatinum
Drug: erlotinib hydrochloride
Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m^2 by mouth once a day beginning day 1.
Other Names:
  • Tarceva(R)
Procedure: radiation therapy
standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
Other Names:
  • irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose of erlotinib hydrochloride
Time Frame: Day 14
Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: 4-6 Weeks Post Last Study Dose
4-6 Weeks Post Last Study Dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

March 1, 2008

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 25, 2007

First Posted (ESTIMATE)

January 29, 2007

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006LS019
  • UMN-0604M84827 (OTHER: IRB, University of Minnesota)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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