Who is sponsoring NCT00086957?

NCT00086957 is sponsored by City of Hope Medical Center.

What condition does NCT00086957 study?

NCT00086957 studies Breast Cancer.

What drugs are being tested in NCT00086957?

Interventions: trastuzumab, docetaxel, gefitinib.

What is the status of NCT00086957?

NCT00086957 is currently COMPLETED.

Last reviewed 2017-01-06 · How we verify

Phase I/II Trial of ZD1839 (Iressa®), Trastuzumab (Herceptin®), and Docetaxel (Taxotere®) in Patients With erbB-2 (HER-2) Overexpressing, Stage IV Breast Carcinoma

NCT00086957 Phase 1/Phase 2 COMPLETED Results posted

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and trastuzumab with docetaxel may kill more tumor cells. PURPOSE: This phase I/II trial is studying the best dose of docetaxel when given together with gefitinib and trastuzumab in treating patients with metastatic breast cancer.

Details

Lead sponsor	City of Hope Medical Center
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	31
Start date	2004-01
Completion	2015-08

Conditions

Breast Cancer

Interventions

trastuzumab
docetaxel
gefitinib

Primary outcomes

Number of Participants With at Least One Dose Limiting Toxicity in Phase I — 4 weeks from start of treatment, up to 2 years
Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater except for hematological toxicities which must be grade 4. Interstitial Lung Disease (ILD) related to treatment should be considered as a DLT regardless of the grade.
Recommended Phase II Dose — 4 weeks from start of treatment, up to 2 years
The maximum tolerated dose (MTD): subjects received gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m\^2 intravenously every 3 weeks. This was to serve as the phase II dose if no dose-limiting toxicities (DLTs) occurred in the first three subjects. If one DLT occurred in the first three subjects, another three subjects where to be enrolled at this dose, whereas if two DLTs occurred in the first three subjects, the docetaxel dose was to be decreased to 60 mg/m\^2. The study would then be continued only if no more than one patient had a DLT at this dose. Once the dose of docetaxel was established, all further subjects were to be treated at the phase II MTD dose.

Countries

United States