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

University of Minnesota (UMN)

Status and phase: Withdrawn; Phase 1

Conditions: Cervical Cancer

Treatments: Procedure: radiation therapy; Drug: cisplatin; Drug: erlotinib hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00428194

2006LS019

UMN-0604M84827 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Cohort 1

Experimental group

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

Treatment:

Procedure: radiation therapy

Drug: erlotinib hydrochloride

Drug: cisplatin

Cohort 2

Experimental group

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

Treatment:

Procedure: radiation therapy

Drug: erlotinib hydrochloride

Drug: cisplatin

Cohort 3

Active Comparator group

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

Treatment:

Procedure: radiation therapy

Drug: erlotinib hydrochloride

Drug: cisplatin