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
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- Withdrawn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
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
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
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
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
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
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
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
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
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)