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

NCT00088946 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-07-31

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Polyphenon E

4-200mg capsules PO daily for 12 months

DRUG

erlotinib hydrochloride

100 mg PO daily for 12 months

OTHER

Erlotinib placebo

identical to Erlotinib in look and appearance of dosing.

OTHER

Polyphenon E

identical to Polyphenon E in look and appearance of dosing.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Arie Belldegrun, MD, FACS · Jonsson Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00088946 on ClinicalTrials.gov