Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Sunitinib Malate Schedule 4/2; Drug: Sunitinib Malate Continuous Daily Dosing

Study type: Interventional

Funder types: Industry

Identifiers

NCT00267748

A6181065

Details and patient eligibility

About

This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment.

The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.

Enrollment: 317 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology.
• Measurable disease

Exclusion criteria

• Prior systemic therapy of any kind for advanced renal cell cancer
• History of brain metastases
• Uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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317 participants in 2 patient groups

C

Experimental group

Treatment:

Drug: Sunitinib Malate Continuous Daily Dosing

A

Experimental group

Treatment:

Drug: Sunitinib Malate Schedule 4/2