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

Primary Purpose

Cervical Cancer

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cisplatin
erlotinib hydrochloride
radiation therapy
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring stage IIA cervical cancer, stage IB cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Maximum tolerated dose of erlotinib hydrochloride

Secondary Outcome Measures

Toxicity

Full Information

First Posted
January 25, 2007
Last Updated
November 27, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00428194
Brief Title
Erlotinib, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB-Stage IVA Cervical Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn due to lack of accrual
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
stage IIA cervical cancer, stage IB cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 3
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
cisplatinum, CDDP
Intervention Description
40 mg/m^2 every 7 days during radiation
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Other Intervention Name(s)
Tarceva(R)
Intervention Description
Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m^2 by mouth once a day beginning day 1.
Intervention Type
Procedure
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
irradiation
Intervention Description
standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
Primary Outcome Measure Information:
Title
Maximum tolerated dose of erlotinib hydrochloride
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
4-6 Weeks Post Last Study Dose

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levi S. Downs, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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