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

This study is currently recruiting patients.

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
transitional cell carcinoma of the bladder
stage 0 bladder cancer
stage I bladder cancer
 Drug: erlotinib
 Drug: green tea extract
 Procedure: adjuvant therapy
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: complementary and alternative therapy
 Procedure: enzyme inhibitor therapy
 Procedure: herbal medicine / botanical therapy
 Procedure: protein tyrosine kinase inhibitor therapy
Phase II

MedlinePlus related topics:  Bladder Cancer;   Cancer
Genetics Home Reference related topics:  bladder cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Randomized Study of Adjuvant Erlotinib and Green Tea Extract (Polyphenon® E) in Preventing Recurrence and Progression in Former Smokers With Resected High-Grade Superficial Transitional Cell Carcinoma of the Bladder

Further Study Details: 

OBJECTIVES: Primary

Secondary

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (Ta vs T1 vs carcinoma in situ) and participating center. Patients are randomized to 1 of 3 treatment arms.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 330 patients (110 per treatment arm) will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell carcinoma (TCC) of the bladder
  • Ta or T1 papillary TCC OR carcinoma in situ TCC
  • Grade 2 or 3 disease
  • Patients with grade 2 papillary tumors must meet at least 1 of the following criteria:
  • At least 2 multiple, synchronous tumors
  • A single tumor > 3 cm in size
  • Newly diagnosed or recurrent tumor within the past 3 months AND rendered disease-free by prior standard surgery and/or intravesical therapy
  • Transurethral resection of bladder within the past 3 months required
  • No involvement of the upper urinary tract prior to or at the time of tumor resection
  • Abdominal CT scan, intravenous pyelogram, or retrograde pyelogram must be performed within the past 12 months to rule out upper urinary tract tumor
  • Former smoker AND ceased smoking for ≥ 12 months before study entry

PATIENT CHARACTERISTICS: Age

  • Over 18

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC > 3,000/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 10 g/dL

Hepatic

  • AST and ALT < 1.5 times upper limit of normal
  • Bilirubin < 1.5 mg/dL

Renal

  • Creatinine < 1.5 mg/dL

Pulmonary

  • Obstructive lung disease (i.e., FEV_1 < 80% of predicted and FEV_1/FVC ratio < 90% of predicted) allowed provided chest radiograph does not demonstrate interstitial changes
  • No idiopathic pulmonary fibrosis
  • No evidence of parenchymal restrictive lung disease on pulmonary function test as indicated by the following criteria:
  • Vital capacity and total lung capacity ≥ 80% of predicted
  • DLCO ≥ 75% of predicted (corrected for hemoglobin)
  • Patients with DLCO < 75% of predicted must undergo evaluation by a pulmonologist and/or high-resolution chest CT scan to rule out interstitial lung disease
  • No asthma requiring active treatment
  • No other interstitial lung disease

Ophthalmic

  • No significant ophthalmic abnormalities
  • No contact lens use

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No connective tissue disease, including the following:
  • Scleroderma
  • Rheumatoid arthritis
  • Sjögren's syndrome
  • Sarcoidosis
  • No environmental or occupational metal or wood dust exposure
  • No significant medical or psychiatric condition that would preclude study participation
  • No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

Endocrine therapy

  • More than 4 weeks since prior high-dose steroids

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • More than 4 weeks since prior anticancer therapy
  • More than 4 weeks since prior experimental drugs
  • More than 12 months since prior amiodarone, methotrexate, isoniazid, minocycline, or nitrofurantoin
  • No normal consumption of > 5 cups of green tea daily
  • No concurrent CYP3A4 inducers, including any of the following:
  • Phenytoin
  • Carbamazepine
  • Hypericum perforatum (St. John's wort)
  • Rifampin
  • Grapefruit juice
  • No concurrent CYP3A4/5 inhibitors or metabolizers (e.g., erythromycin or ketoconazole)
  • No concurrent tricyclic antidepressants, including imipramine, dothiepin, and mianserin

Location and Contact Information


Arizona
      Bladder Cancer Genitourinary Oncology, P.C., Phonix,  Arizona,  85032,  United States; Recruiting
Donald L. Lamm, MD  602-493-6626 

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1738,  United States; Recruiting
Arie Belldegrun, MD, FACS  310-794-6584    abelldegrun@mednet.ucla.edu 

      Santa Monica UCLA Medical Center, Santa Monica,  California,  90404,  United States; Recruiting
James Orecklin, MD  310-451-8751    jorecklin@mednet.ucla.edu 

      Veterans Affairs Medical Center - West Los Angeles, Los Angeles,  California,  90073,  United States; Recruiting
William Aronson, MD  310-268-3446 

Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Bradley C. Leibovich, MD  507-284-2511 

Study chairs or principal investigators

Arie Belldegrun, MD, FACS,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000377681; UCLA-0301091-02; NCT00088946
Record last reviewed:  January 2005
Last Updated:  April 4, 2005
Record first received:  August 4, 2004
ClinicalTrials.gov Identifier:  NCT00088946
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005