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

NCT00467077 | Terminated Phase 2 Results

• 6 other identifiers: CDR0000540598P30CA093373CCC-PHII-40ZENECA-AZ1839US/0227UCD-200412338-4UCD-ZD1839
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer; stage IV renal cell cancer; stage III renal cell cancer

Outcome Measures

Primary Outcomes (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

  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)

• Number of Participants With Overall Response as Measured by RECIST Criteria

  After 2 cycles of treatment, up to 2 years.

• Progression-Free Survival

  Until disease progression, up to 5 years.

• Overall Survival

  Up to 5 years.

Study Arms (1)

Gefitinib and PEG-IFNa Treatment

EXPERIMENTAL

Gefitinib 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).

Biological: PEG-interferon alfa-2b; Drug: gefitinib

Interventions

PEG-interferon alfa-2b BIOLOGICAL

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

Gefitinib and PEG-IFNa Treatment

gefitinib DRUG

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

Gefitinib and PEG-IFNa Treatment

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• California Cancer Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

• 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.

  PMID: 21431345 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

peginterferon alfa-2b; Gefitinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Protocol was closed prior to the second stage of accrual (pegged at n = 24) due to slow accrual. The reason for the slow accrual was likely the availability of several new Food and Drug Administration approved targeted agents during the study period.

Results Point of Contact

• Title: DCC Project Administrator
• Organization: California Cancer Consortium

CCCP@coh.org

626-256-4673

Study Officials

• Primo N. Lara, MD

  University of California, Davis

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: September 1, 2004
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 17, 2017
• Results First Posted: March 17, 2017

Record last verified: 2017-01

Locations

US (3)