Clinical trial · Interventional
Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
Phase II Trial of ZD1839 (IRESSA®) and Pegylated Interferon Alfa 2b (PEG-Intron™) in Unresectable or Metastatic Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Protocol was closed due to slow accrual.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
| PEG-interferon alfa-2b | Biological | Peginterferon Alfa-2b | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gefitinib and PEG-IFNa Treatment
- description
- 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).
- interventionNames
- Biological: PEG-interferon alfa-2b
- Drug: gefitinib
Primary outcomes (1)
- measure
- Six-month Progression-free Survival
- timeFrame
- 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
- description
- 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
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDShek 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