Clinical trial NCT00428194: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: 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
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2007-01-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximum tolerated dose of erlotinib hydrochloride
timeFrame: Day 14
Secondary outcomes:
measure: Toxicity
timeFrame: 4-6 Weeks Post Last Study Dose
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Levi S. Downs, MD
role: STUDY_CHAIR
References: