Erlotinib and Green Tea Extract (Polyphenon® E) in Preventing Cancer Recurrence in Former Smokers Who Have Undergone Surgery for Bladder Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT00088946
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Polyphenon E — DIETARY_SUPPLEMENT
    4-200mg capsules PO daily for 12 months
  • erlotinib hydrochloride — DRUG
    100 mg PO daily for 12 months
  • Erlotinib placebo — OTHER
    identical to Erlotinib in look and appearance of dosing.
  • Polyphenon E — OTHER
    identical to Polyphenon E in look and appearance of dosing.

Study Details

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Green tea extract (Polyphenon® E) contains certain ingredients that may slow the growth of tumor cells and prevent the recurrence of cancer. Giving erlotinib or green tea extract after surgery may kill any remaining tumor cells and may prevent the recurrence of bladder cancer. PURPOSE: This randomized phase II trial is studying how well giving erlotinib together with green tea extract works in preventing cancer recurrence in former smokers who have undergone surgery for bladder cancer.

Key Dates

First listed
Aug 5, 2004
Start date
May 31, 2004
Status verified
Aug 2012
Primary completion
Jul 31, 2006
Completion
Jul 31, 2006

Study Design

Enrollment
17 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Polyphenon E plus erlotinib placebo daily for 12 months.
  • Experimental: Arm 2
    Erlotinib and Polyphenon E placebo daily for 12 months.
  • Placebo Comparator: Arm 3
    Erlotinib placebo and Polyphenon E placebo daily for 12 months.

Primary Outcome Measure

Evaluate the effects of a daily oral dose of polyphenon E, erlotinib, or placebo on subjects who are former smokers with a history of superficial bladder cancer on the bladder cancer recurrence rate at two years of any stage or grade of bladder cancer. [ Time Frame: 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Bladder Cancer Genitourinary Oncology, PCPhoenixArizona85032-
Jonsson Comprehensive Cancer Center at UCLALos AngelesCalifornia90095-1781-
Veterans Affairs Medical Center - West Los AngelesLos AngelesCalifornia90073-
Santa Monica UCLA Medical CenterSanta MonicaCalifornia90404-
Mayo Clinic Cancer CenterRochesterMinnesota55905-

Find similar trials in Phoenix, AZ

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Bladder Cancer Genitourinary Oncology, PC· Phoenix, AZJonsson Comprehensive Cancer Center at UCLA· Los Angeles, CAVeterans Affairs Medical Center - West Los Angeles· Los Angeles, CASanta Monica UCLA Medical Center· Santa Monica, CAMayo Clinic Cancer Center· Rochester, MN

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