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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00428194
• Other study ID #: 2006LS019
• Secondary ID: UMN-0604M84827
• Status: Withdrawn
• Phase: Phase 1
• First received: January 25, 2007
• Last updated: November 27, 2017
• Start date: January 2007
• Est. completion date: March 2008

Study information

• Verified date: November 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• cisplatin
40 mg/m^2 every 7 days during radiation
• erlotinib hydrochloride
Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m^2 by mouth once a day beginning day 1.

Procedure:
• radiation therapy
standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)

Locations

Country	Name	City	State
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of erlotinib hydrochloride		Day 14
Secondary	Toxicity		4-6 Weeks Post Last Study Dose