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

Primary Purpose

Kidney Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PEG-interferon alfa-2b

gefitinib

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer, stage III renal cell cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

City of Hope Comprehensive Cancer Center
USC/Norris Comprehensive Cancer Center and Hospital
University of California Davis Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gefitinib and PEG-IFNa Treatment

Arm 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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Overall Survival

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

Full Information

NCT ID

NCT00467077

First Posted

April 25, 2007

Last Updated

January 30, 2017

Sponsor

California Cancer Consortium

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00467077

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Terminated

Why Stopped

Protocol was closed due to slow accrual.

Study Start Date

September 2004 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

California Cancer Consortium

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

Keywords

recurrent renal cell cancer, stage IV renal cell cancer, stage III renal cell cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gefitinib and PEG-IFNa Treatment

Arm Type

Experimental

Arm 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).

Intervention Type

Biological

Intervention Name(s)

PEG-interferon alfa-2b

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

gefitinib

Intervention Description

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

Primary Outcome Measure Information:

Title

Six-month Progression-free Survival

Description

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

Secondary Outcome Measure Information:

Title

Number of Participants With Overall Response as Measured by RECIST Criteria

Description

Time Frame

After 2 cycles of treatment, up to 2 years.

Title

Progression-Free Survival

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 the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time Frame

Until disease progression, up to 5 years.

Title

Overall Survival

Description

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

Time Frame

Up to 5 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Primo N. Lara, MD

Organizational Affiliation

University of California, Davis

Official's Role

Study Chair

Facility Information:

Facility Name

City of Hope Comprehensive Cancer Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010-3000

Country

United States

Facility Name

USC/Norris Comprehensive Cancer Center and Hospital

City

Los Angeles

State/Province

California

ZIP/Postal Code

90089-9181

Country

United States

Facility Name

University of California Davis Cancer Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21431345

Citation

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.

Results Reference

derived

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

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