Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma

NCT00556049 | Completed Phase 2 Results

• 1 other identifier: 07-212
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this research study is to determine if the combination of sunitinib and gemcitabine is effective in treating patients with metastatic renal cell carcinoma. The safety of this combination will also be studied. Sunitinib is approved by the FDA for the treatment of renal cell carcinoma. However, some patients' cancers do not respond to treatment or stops responding after initially responding. Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of pancreatic cancer and several other cancers. It is not approved for the treatment of renal cell carcinoma. Previous research has suggested that combining gemcitabine with sunitinib may have some effectiveness in treating metastatic renal cell carcinoma.

Conditions

Renal Cell Carcinoma; Neoplasm Metastases

Keywords

mRCC; sunitinib; gemcitabine

Outcome Measures

Primary Outcomes (1)

• To Determine the Overall Response Rate of Combination Therapy With Gemcitabine and Sunitinib in Sarcomatoid and/or Poor-risk mRCC Patients as First Line Therapy.

  Until disease progression

Study Arms (1)

1

EXPERIMENTAL

Sunitinib and gemcitabine

Drug: Gemcitabine; Drug: Sunitinib

Interventions

Gemcitabine DRUG

Intravenously on days 1 and 8 of each 21-day treatment cycle.

Also known as: Gemzar

1

Sunitinib DRUG

Orally on days 1-14 of each 21-day treatment cycle

Also known as: Sutent

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven metastatic renal cell carcinoma with any sarcomatoid histology or poor-risk features as defined by having 3 or more of the following characteristics:
• PS \> 1, high serum lactate dehydrogenase
• low hemoglobin
• high "corrected" serum calcium
• or more sites of metastatic disease
• time from initial diagnosis to evidence of metastatic disease 12 months or less
• Evidence of unidimensional measurable disease based on RECIST criteria, with at least 1 measurable lesion
• Male or female, 18 years of age or older
• ECOG performance status of 0-2
• Patients with brain metastasis can only be included of they were treated 4 weeks or more prior to enrollment with whole brain radiation and the effects of treatment have resolved
• Resolution of all acute toxic effects of prior therapy, radiotherapy or surgical procedure to NCI CTCAE version 3.0 grade of 1 or less
• Laboratory values as outlined in the protocol
• weeks or more must have elapsed from the time of major surgery or radiation therapy prior to the day of registration
• No anticipated need for major surgical procedure during the course of the study

You may not qualify if:

• Prior treatment with sunitinib or gemcitabine
• More than one prior systemic therapy of any kind for renal cell carcinoma
• Uncontrolled high blood pressure
• Any prior history of hypertensive crisis or hypertensive encephalopathy
• Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, or symptomatic congestive heart failure
• Ejection fraction \< 30%
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
• NCT CTCAE grade 3 or higher hemorrhage within 4 weeks of starting treatment
• Significant vascular disease
• Current grade 3 or higher cardiac dysrhythmia or QT prolongation
• Concurrent use of proarrhythmic medications including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide
• Pregnancy or breastfeeding or inadequate contraception
• Evidence of bleeding diathesis or coagulopathy
• Serious, non-healing wound, ulcer or bone fracture
• Psychiatric illness/social situation that would limit compliance with study requirements

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Pfizer: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center'

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

Gemcitabine; Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Pyrroles; Azoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. M. Dror Michaelson
• Organization: MGH Cancer Center

dmichaelson1@partners.org

617-726-1594

Study Officials

• M. Dror Michaelson, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 9, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: April 21, 2016
• Results First Posted: April 3, 2015

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)