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Kidney CancerPhase 2NCT00467077

Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer

A Phase 2 study testing PEG-interferon alfa-2b and gefitinib in people with Kidney Cancer, run by California Cancer Consortium at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Gefitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PEG-interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of kidney cancer. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Kidney Cancer
What is being tested?
PEG-interferon alfa-2b and gefitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
3 sitesUnited States
Study dates
Sep 2004to Mar 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed renal cell carcinoma
  • Metastatic or advanced/unresectable disease
  • Measurable or nonmeasurable disease as defined by RECIST criteria
  • No uncontrolled brain metastases
  • Patients with adequately treated brain metastases who are not taking anticonvulsants and corticosteroids may be eligible

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 12 weeks
  • WBC ≥ 3,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Absolute granulocyte count ≥ 1,500/mm³
  • Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min
  • Bilirubin ≤ 1.5 mg/dL
  • AST ≤ 2 times upper limit of normal (ULN)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently in complete remission
  • No known severe hypersensitivity to gefitinib or its excipients
  • No incomplete healing from previous oncologic or other major surgery
  • No unresolved chronic toxicity > grade 2 from previous anticancer therapy (except alopecia and anemia)
  • No evidence of clinically active interstitial lung disease
  • Patients with chronic stable radiographic changes who are asymptomatic are eligible
  • No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • No other significant clinical disorder or laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • More than 30 days since prior nonapproved or investigational drugs
  • More than 6 weeks since prior aldesleukin or interferon and recovered
  • At least 3 weeks since prior radiotherapy
  • No prior gefitinib
  • Prior chemotherapy or biological therapy allowed
  • Prior or concurrent bisphosphonate therapy for bone metastases allowed
  • No concurrent phenytoin, carbamazepine, rifampin, barbiturates, phenobarbital, or Hypericum perforatum (St. John's wort)
  • No other concurrent agents specifically designed to inhibit the epidermal growth factor receptor (EGFR)
  • No concurrent radiotherapy to measurable lesions

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • University of California Davis Cancer Center

    Sacramento, California, 95817

Other trials in United States

About this study

Official title: Phase II Trial of ZD1839 (IRESSA®) and Pegylated Interferon Alfa 2b (PEG-Intron™) in Unresectable or Metastatic Renal Cell Carcinoma

RATIONALE: Gefitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PEG-interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of kidney cancer. Giving gefitinib together with PEG-interferon alfa-2b may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gefitinib together with PEG-interferon alfa-2b works in treating patients with unresectable or metastatic kidney cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the 6-month progression-free survival of patients with unresectable or metastatic renal cell carcinoma treated with gefitinib and PEG-interferon alfa-2b.

Secondary

  • Determine the response rate (by RECIST criteria), duration of response, time to treatment failure, and overall survival of patients treated with this regimen.
  • Assess toxicity and tolerability of this regimen in these patients.
  • Determine the pre-treatment expression of the von Hippel-Lindau (VHL) protein, the epidermal growth factor receptor (EGFR), and p27, and correlate with response to treatment.
  • Determine post-treatment alteration of EGFR and p27 expression in patients with tumors accessible for serial biopsy.
  • Assess changes in EGFR levels in buccal epithelial cells in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib once daily and PEG-interferon alfa-2b subcutaneously once weekly in weeks 1-6. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response or stable disease after completion of course 2 continue to receive gefitinib alone as above in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Conditions
Kidney Cancer
Being tested
PEG-interferon alfa-2b, gefitinib
Keywords
recurrent renal cell cancer, stage IV renal cell cancer, stage III renal cell cancer
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

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

  • PEG-interferon alfa-2bBiological

    PEG-Interferon will be administered subcutaneously (sq) once weekly for 6 weeks

  • gefitinibDrug

    ZD1839 will be administered at a dose of 250 mg orally once daily,

Study groups in NCT00467077
Study groupRoleWhat they receive
Gefitinib and PEG-IFNa TreatmentExperimentalGefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
Receives: Biological: PEG-interferon alfa-2b; Drug: gefitinib

What is being measured

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

  1. Six-month Progression-free Survival

    Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions

    Measured: From the date treatment started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Secondary outcomes (3)

  1. Number of Participants With Overall Response as Measured by RECIST Criteria

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response = CR + PR

    Measured: After 2 cycles of treatment, up to 2 years.

  2. Progression-Free Survival

    Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: Until disease progression, up to 5 years.

  3. Overall Survival

    Estimated using the product-limit method of Kaplan and Meier.

    Measured: Up to 5 years.

Timeline

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

  1. First posted27 Apr 2007 (estimated)
  2. Study startSep 2004
  3. Primary completionMar 2011
  4. Study completionMar 2011

Why it stopped: Protocol was closed due to slow accrual.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00467077
Sponsor's protocol ID
CDR0000540598
Other IDs
P30CA093373, CCC-PHII-40, ZENECA-AZ1839US/0227, UCD-200412338-4, UCD-ZD1839
Status last verified
Jan 2017
First submitted
25 Apr 2007
Last updated
17 Mar 2017

Publications

  • Shek D, Longmate J, Quinn DI, Margolin KA, Twardowski P, Gandara DR, Frankel P, Pan CX, Lara PN Jr. A phase II trial of gefitinib and pegylated IFNalpha in previously treated renal cell carcinoma. Int J Clin Oncol. 2011 Oct;16(5):494-9. doi: 10.1007/s10147-011-0212-8. Epub 2011 Mar 23.

    PubMed 21431345

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PEG-interferon alfa-2b and gefitinib in people with Kidney Cancer, run by California Cancer Consortium at 3 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?

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: stopped early, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. 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?

Yes. Results are posted in the registry (first posted 17 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Six-month Progression-free Survival (time frame: From the date treatment started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months). 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 NCT00467077, which also lists 1 linked publication.

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 17 Mar 2017.

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