Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Recurrence

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Interferons

Sorafenib

Interferon-alpha

Interferon alpha-2

Antiviral Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunologic Factors

Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.

Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.

Given orally 400 mg orally (PO) every 12 hours

Sorafenib Tosylate

Given subcutaneously (SC) 0.5 million with +/- 5 % variance (0.475 MU - 0.525 MU); Dose level 0: 0.5 X 10\^6 international units twice daily

Recombinant Interferon Alfa-2b

Laboratory Biomarker Analysis

Eric Jonasch

This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well they work compared to sorafenib alone in treating patients with metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with interferon alfa-2b may kill more tumor cells.

PRIMARY OBJECTIVES:

I. Efficacy of Bay 43-9006 with or without low dose interferon by evaluating response rate in MRCC.

II. Toxicities of Bay 43-9006 with or without low dose interferon in MRCC.

SECONDARY OBJECTIVES:

I. Progression free survival. II. Duration of response. III. Overall Survival.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral sorafenib twice daily on days 1-28.

Arm II: Patients receive sorafenib as in arm I and low-dose interferon alfa-2b subcutaneously twice daily on days 1-28.

In both arms, courses repeat every 28 days in the absence of progressive disease or unacceptable toxicity.

Tissue samples are analyzed for single nucleotide polymorphisms (SNP) patterns via genotyping.

After completion of study treatment, patients are followed every 3 months.

Sorafenib Tosylate With or Without Recombinant Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer

A Phase II Clinical Trial to Evaluate the Efficacy of BAY 43-9006 With or Without Low Dose Interferon in Metastatic Renal Cell Carcinoma

ORR defined as participants with Complete Response (CR) and Partial Response (PR) as defined by RECIST criteria: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): \>30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): \>20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.

Adverse events graded using the CTCAE version 4.0 tabulated by treatment arm within either toxicity grade for the treatment period. Treatment-related toxicity (acute and cumulative) performed every 8 weeks during the first year.

Progression free survival (PFS) is defined as the time interval from the start of protocol therapy to death or disease progression.

Overall survival defined as the time interval from the start of protocol therapy to death or date of last follow-up if alive.

Duration of response for participants with disease stabilization following treatment as measured from the date response is confirmed to the date of disease progression, first assessed up to 8 weeks (2 cycles) following start of treatment. The duration of a Stable Disease (SD) response is measured from the time measurement criteria are met for that specific SD response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Repeat radiologic studies (CT, MRI, Chest x-ray and bone scan as indicated) to evaluate disease progression or response every 8 weeks.

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.

Sorafenib Tosylate, Recombinant Interferon Alfa-2b

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Eastern Cooperative Oncology Group (ECOG) Scale used to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Scale runs from 0 to 5, with 0 denoting perfect health and 5 death.

ECOG (Performance Status)

Number of participants who had nephrectomy

Nephrectomy

Intermediate

Poor

MSKCC risk system stratifies participants poor, intermediate and favorable-risk categories based on number of adverse clinical/laboratory parameters present. Poor prognostic factors include Karnofsky performance status \<80, time from diagnosis to treatment \<12 months, serum lactate dehydrogenase \>1.5-times upper limit of normal, corrected serum calcium \>10.0 mg/dl \& hemoglobin \<lower limit of normal. Favorable-risk group have no poor prognostic factors, intermediate-risk category have 1 or 2 adverse prognostic factors, \& participants with poor-risk have \>2 poor prognostic factors.

Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Risk

Three or More

Number of Metastatic Sites

Lung

Lymph Nodes

Liver

Bone

Other

Number of participants with metastatic tumor sites in the noted locations for each study arm population.

Sites of Metastatic Disease

Eric Jonasch, MD/Associate Professor, Genitourinary Medical Oncology

Analysis performed for the intent-to-treat population.

Objective Response Rate (ORR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST)

Fatigue

Diarrhea

Hand-Foot Syndrome

Hyperuricemia

Hyperamylasemia or Lipasemia

Dyspnea

Hypophosphatemia

Neutropenia

Hypertension

Nausea and vomiting

Rash/Desquamation

Proteinuria

Syncope (Fainting)

Weight Loss

Transaminitis

Hyponatremia

Nonneutropenic Infection

Sensory Neuropathy

Cardiac Ischemia/Infarction

Appendicitis

Pancreatitis

Adrenal Insufficiency

Reversible Posterior Leukonencephalopathy

Small Bowel Obstruction

Pneumonitis

All participants were included in adverse event reporting per intent to treat analysis.

Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

All participants were included per intent to treat analysis.

Progression-free Survival

Participants who die of unrelated cause during therapy or are lost to follow-up were censored. Median OS was not reached in Arm 1: Sorafenib as subjects experienced different events that made further follow-up impossible i.e. disease complications, death or lost to follow-up so overall survival data was not attainable.

Median Overall Survival (OS)

Arm I: Oral Sorafenib 400 mg twice daily on days 1-28 and Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.

Sorafenib Tosylate or Sorafenib Plus Interferon

Combined analysis reflects overall stable disease duration e.g. duration of benefit for stable disease cases without being affected by the median duration not attainable for the separate arms; 37 participants in the two arms met "Stable Disease" criteria: 17 in Sorafenib alone (Arm I) and 20 in the Sorafenib Plus Interferon group (Arm II).

Duration of Response for Participants With Stable Disease (N=37) Following Treatment

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

Progressive Disease (PD)

Inevaluable

Best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The participant's best response assignment will depend on the achievement of both measurement and confirmation criteria as defined by RECIST: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): \>30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): \>20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.

Best Overall Response for Participants

Overall Study

Spots Global Cancer Trial Database for Sorafenib Tosylate With or Without Recombinant Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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