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

This study has been withdrawn prior to enrollment.
(Withdrawn due to lack of accrual)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00428194
First received: January 25, 2007
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Drug: cisplatin
Drug: erlotinib hydrochloride
Procedure: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Maximum tolerated dose of erlotinib hydrochloride [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 4-6 Weeks Post Last Study Dose ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: January 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • cisplatinum
  • CDDP
Drug: erlotinib hydrochloride
Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m^2 by mouth once a day beginning day 1.
Other Name: Tarceva(R)
Procedure: radiation therapy
standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
Other Name: 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:
  • cisplatinum
  • CDDP
Drug: erlotinib hydrochloride
Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m^2 by mouth once a day beginning day 1.
Other Name: Tarceva(R)
Procedure: radiation therapy
standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
Other Name: 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:
  • cisplatinum
  • CDDP
Drug: erlotinib hydrochloride
Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m^2 by mouth once a day beginning day 1.
Other Name: Tarceva(R)
Procedure: radiation therapy
standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
Other Name: irradiation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428194

Locations
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Study Chair: Levi S. Downs, MD Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00428194     History of Changes
Other Study ID Numbers: 2006LS019, UMN-0604M84827
Study First Received: January 25, 2007
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
stage IIA cervical cancer
stage IB cervical cancer
stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014