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
18 Years
N/A
Female
Cervical Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of erlotinib hydrochloride
Outcome Time Frame:
Day 14
Safety Issue:
Yes
Principal Investigator
Levi S. Downs, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Food and Drug Administration
Study ID:
2006LS019
NCT ID:
NCT00428194
Start Date:
January 2007
Completion Date:
March 2008
Related Keywords:
- Cervical Cancer
- stage IIA cervical cancer
- stage IB cervical cancer
- stage IIB cervical cancer
- stage III cervical cancer
- stage IVA cervical cancer
- cervical squamous cell carcinoma
- Carcinoma, Squamous Cell
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
