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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


Phase 1
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

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 CenterMinneapolis, Minnesota  55455