Docetaxel and Erlotinib in Treating Older Patients With Prostate Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT00087035
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • docetaxel — DRUG
    Administered as an IV infusion of 60m/m2 over a 1-hour period, once every 21 ± 2 days
  • erlotinib hydrochloride — DRUG
    Will be taken at a starting daily dose of 150mg

Study Details

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining docetaxel with erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with erlotinib works in treating older patients with progressive prostate cancer that has not responded to hormone therapy.

Key Dates

First listed
Jul 12, 2004
Start date
May 31, 2004
Status verified
Aug 2012
Primary completion
Jun 30, 2006
Completion
Mar 31, 2008

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Taxotere plus Tarceva
    Patients receive Tarceva 150 mg daily for 21 consecutive days (one treatment cycle). In addition, all patients will receive single agent Taxotere 60 mg/m2 IV over 1 hour infusion every 21 ± 2 days and have it administered on day 1. Taxotere + Tarceva to be taken for three cycles past maximal response or until one of the following occurs: 1) a drug-related toxicity requiring discontinuation, 2) disease progression, or 3) for a maximum of 9 cycles. Upon completion of 9 cycles of Taxotere plus Tarceva, patients showing evidence of objective response (CR, PR or stable disease) may continue in the extension phase of the study and receive treatment with Tarceva alone. Treatment response evaluated after four cycles of Tarceva treatment(immediately prior to cycle 14). Patients with progression of disease will be taken off study. Responding and stable disease patients will remain on study for up to 8 extension-phase cycles for a total of 17 cycles.

Primary Outcome Measure

Response [ Time Frame: 9 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Jonsson Comprehensive Cancer Center at UCLALos AngelesCalifornia90095-1781-
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
University Cancer Center at University of Washington Medical CenterSeattleWashington98195-6043-

Find similar trials in Los Angeles, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Jonsson Comprehensive Cancer Center at UCLA· Los Angeles, CASamuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center· Los Angeles, CAUniversity Cancer Center at University of Washington Medical Center· Seattle, WA

Related Studies