Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Conditions

• Head and Neck Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• cisplatin — DRUG
• erlotinib hydrochloride — DRUG

Study Details

RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with cisplatin may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib and cisplatin in treating patients who have recurrent or metastatic head and neck cancer.

Key Dates

First listed

Jan 27, 2003

Start date

Nov 30, 2001

Status verified

Oct 2018

Primary completion

Dec 31, 2009

Completion

Dec 31, 2009

Study Design

Enrollment

51 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: OSI-774 and cisplatin
  HNSCC patients treated in three escalating dose cohorts of daily continous oral erlotinib (OSI-774) and intermittent IV cisplatin given every 21 days

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