Clinical trial NCT00098618: Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
Official title: A Phase 2 Study Of BAY 43-9006 In Combination With Interferon Alfa-2b In Metastatic Renal Cell Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Clear Cell Renal Cell Carcinoma
Papillary Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth or by blocking blood flow to the tumor. Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer. Sorafenib may help interferon alfa kill more tumor cells by making tumor cells more sensitive to the drug. Giving sorafenib together with interferon alfa may kill more tumor cells. This phase II trial is studying how well giving sorafenib with interferon alfa works in treating patients with locally advanced or metastatic kidney cancer.

Detailed description: PRIMARY OBJECTIVES:

I. Determine the feasibility and tolerability of sorafenib and interferon alfa in patients with locally advanced or metastatic renal cell carcinoma.

II. Determine the response rate (complete response and partial response) in patients treated with this regimen.

SECONDARY OBJECTIVES:

I. Determine the progression-free survival and response duration of patients treated with this regimen.

II. Correlate changes in laboratory parameters with response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily and interferon alfa subcutaneously three times a week for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients with stable or responding disease are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for 1 year or until disease progression.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 10 months.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed renal cell carcinoma

  * Locally advanced or metastatic disease
  * All histologic subtypes allowed
* Measurable disease

  * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* No known brain metastases or leptomeningeal disease
* Performance status - ECOG 0-2
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No bleeding diathesis
* Bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN
* Creatinine clearance ≥ 60 mL/min
* No uncontrolled hypertension
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of sensitivity to E. coli-derived products
* No history of severe depression
* No active infection requiring antibiotics
* No seizure disorder requiring antiepileptic medication
* No medical condition likely to require systemic corticosteroids
* No autoimmune disorder that could result in life-threatening complications
* No other uncontrolled illness
* No psychiatric illness or social situation that would preclude study compliance
* No more than 1 prior biologic response modifier regimen
* At least 4 weeks since prior biologic response modifiers
* No prior interferon alfa
* No prior chemotherapy
* At least 4 weeks since prior radiotherapy to non-index lesions

  * Prior radiotherapy to index lesion allowed provided irradiated lesion progressed ≥ 20% in diameter
* At least 2 weeks since prior major surgery
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent therapeutic anticoagulation therapy

  * Concurrent prophylactic anticoagulation, such as low-dose warfarin, for venous or arterial access device allowed provided PT, PTT, and INR are normal
* No other concurrent investigational agents
* No other concurrent anticancer therapy

Primary outcomes:
measure: Overall response rate (CR+PR) using RECIST criteria
timeFrame: Up to 5 years
measure: Grade 3+ toxicities assessed using NCI CTCAE version 3.0
timeFrame: Up to 5 years
measure: Progression-free survival
timeFrame: Up to 5 years
measure: Overall survival
timeFrame: Up to 5 years
measure: Duration of response
timeFrame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented , assessed up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Daniel George
role: PRINCIPAL_INVESTIGATOR
References: