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Bladder CancerPhase 2NCT00088946

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

A Phase 2 study testing Polyphenon E and erlotinib hydrochloride in people with Bladder Cancer, run by Jonsson Comprehensive Cancer Center at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Polyphenon E and erlotinib hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
5 sitesUnited States
Study dates
May 2004to Jul 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be former smokers and have ceased smoking at study entry.
  • Participants with any previous history of prior cancer diagnosis of Grade 1, 2, or 3, Ta or T1 papillary TCC, or CIS TCC, histologically confirmed, with a newly diagnosed or recurrent tumor within 6 months of accrual who are rendered disease free by standard of care. Patients with Grade 1 papillary tumors must meet at least one of the following additional criteria:
  • multiple, synchronous tumors (>2)
  • a single tumor greater than 1 cm in size
  • At study entry, patients must have no evidence of disease
  • Participants may have been previously treated with intravesical therapy.
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  • Age>18 years
  • Transurethral resection of bladder tumor within 6 months prior to entry on to study
  • Participants must have a signed written informed consent
  • Agreement with complete abstinence from heterosexual intercourse or with the use of contraception during the treatment phase in women of childbearing potential
  • Negative pregnancy test in women of childbearing potential
  • Patients must have adequate bone marrow function at study entry (WBC>3000, platelets>100000/mm3, and hemoglobin>10g/dl)
  • Patients must have satisfactory renal and hepatic function, defined as plasma creatinine of < 1.5mg/dl, total bilirubin < 1.5, and AST/ALT < 1.5 x the upper limit of normal
  • Patients with evidence of obstructive lung disease as the etiology of a low diffusing capacity will still be eligible as long as the chest radiograph does not demonstrate interstitial changes

Who cannot join

  • Prior chemotherapy or radiotherapy
  • Prior (within 2 years) or concurrent malignancies, except non-melanomatous skin tumors or carcinoma in situ of the cervix
  • Significant medical or psychiatric condition that would make the participant a poor protocol candidate
  • TCC greater than or equal to T2 at most recent diagnosis
  • Involvement of the upper urinary tract prior to or at the time of initial tumor resection
  • Prior treatment with experimental drugs, high dose steroids, or with any other cancer treatment within 4 weeks prior to the first dose of study drug and for the duration of the study
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  • Positive pregnancy test at any time throughout the course of the study
  • Normal consumption of greater than 5 cups of green tea daily
  • Participants taking a known CYP 3A4 inducer or food products and medications known to be inhibitors or metabolized by CYP3A4/5 such as erythromycin, ketoconazole, etc. will be excluded since these drugs may be expected to result in altered exposure of Erlotinib
  • ECOG performance status > 1
  • History of idiopathic pulmonary fibrosis or other interstitial lung disease
  • Use of tricyclic antidepressants, including imipramine, dothiepin, and mianserin
  • Use within the last 12 months of amiodarone, methotrexate, isoniazid, minocycline, or nitrofurantoin
  • History of environmental or occupational metal dust or wood dust exposure
  • History of connective tissue disease, including scleroderma, rheumatoid arthritis, Sjogren's Syndrome, or sarcoid
  • Significant ophthalmologic abnormalities or patients using contact lenses
  • Evidence of interstitial lung disease on chest radiograph
  • Patients without obvious interstitial lung disease on chest radiograph will be excluded if they have evidence of parenchymal restrictive lung disease on pulmonary function testing as identified by the following criteria:
  • Both vital capacity and total lung capacity <80% of predicted value
  • A diffusing capacity of the lung for carbon monoxide, corrected for hemoglobin, < 75% of predicted value

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Veterans Affairs Medical Center - West Los Angeles

    Los Angeles, California, 90073

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • Bladder Cancer Genitourinary Oncology, PC

    Phoenix, Arizona, 85032

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Santa Monica UCLA Medical Center

    Santa Monica, California, 90404

Other trials in United States

About this study

Official title: Parallel, Randomized, Double-Blind, Placebo Controlled Phase II Adjuvant Studies of Erlotinib and Polyphenon E to Prevent the Recurrence and Progression of Tobacco-Related, Superficial Bladder Cancer

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.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the effects of erlotinib vs green tea extract (Polyphenon® E) vs placebo on the 2-year recurrence rate in former smokers with resected superficial transitional cell carcinoma of the bladder.
  • Develop an effective chemopreventative strategy (as an adjunct to standard care) for the medical management of superficial bladder cancer in these patients.

Secondary

  • Determine the toxic effects associated with these drugs in these patients.
  • Determine a safe and effective chemopreventative dose of erlotinib in these patients.
  • Correlate the modulation of 1 or more biomarkers with bladder cancer recurrence and/or progression in patients treated with these drugs.
  • Determine the risk of clinical bladder cancer progression in patients treated with these drugs.

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.

  • Arm I: Patients receive oral erlotinib and oral green tea extract (Polyphenon® E) placebo once daily.
  • Arm II: Patients receive oral green tea extract (Polyphenon® E) and oral erlotinib placebo once daily.
  • Arm III: Patients receive oral erlotinib placebo and oral green tea extract placebo once daily.

In all arms, treatment continues for 12 months in the absence of disease recurrence or unacceptable toxicity.

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.

Conditions
Bladder Cancer
Being tested
Polyphenon E, erlotinib hydrochloride, Erlotinib placebo
Keywords
transitional cell carcinoma of the bladder, stage 0 bladder cancer, stage I bladder cancer
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polyphenon EDietary supplement

    Also called green tea extract

    4-200mg capsules PO daily for 12 months

  • erlotinib hydrochlorideDrug

    Also called Tarceva

    100 mg PO daily for 12 months

  • Erlotinib placeboOther

    identical to Erlotinib in look and appearance of dosing.

  • Polyphenon EOther

    identical to Polyphenon E in look and appearance of dosing.

Study groups in NCT00088946
Study groupRoleWhat they receive
Arm 1ExperimentalPolyphenon E plus erlotinib placebo daily for 12 months.
Receives: Dietary Supplement: Polyphenon E; Other: Erlotinib placebo
Arm 2ExperimentalErlotinib and Polyphenon E placebo daily for 12 months.
Receives: Drug: erlotinib hydrochloride; Other: Polyphenon E
Arm 3Placebo comparatorErlotinib placebo and Polyphenon E placebo daily for 12 months.
Receives: Other: Erlotinib placebo; Other: Polyphenon E

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Secondary outcomes (4)

  1. To address the unmet need in medical management of superficial bladder cancer as an adjunct to standard of care.

    Measured: 2 years

  2. Assess toxicities associated with daily oral dosing of polyphenon E or erlotinib in subjects at risk for bladder tumor recurrence and to define a safe and effective prevention dose of erlotinib.

    Measured: 2 years

  3. Correlate the modulation of one or more biomarkers with recurrence of bladder cancer confirming the value as a surrogate endpoint biomarker for bladder cancer recurrence and/or progression.

    Measured: 2 years

  4. To assess the risk of clinical bladder cancer progression in patients treated with polyphenon E, erlotinib or placebo.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2004 (estimated)
  2. Study startMay 2004
  3. Primary completionJul 2006
  4. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00088946
Sponsor's protocol ID
CDR0000377681
Other IDs
UCLA-0301091-03
Status last verified
Aug 2012
First submitted
4 Aug 2004
Last updated
31 Jul 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Polyphenon E and erlotinib hydrochloride in people with Bladder Cancer, run by Jonsson Comprehensive Cancer Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00088946.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.

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