Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma
NCT00556049
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 2 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
- 2 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
- 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
- Previous diagnosis of concurrent malignancy requiring active systemic therapy
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma | |||
Official Title ICMJE | Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma | |||
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. | |||
Detailed Description |
| |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Experimental: 1
Sunitinib and gemcitabine Interventions:
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 72 | |||
Original Estimated Enrollment ICMJE | 36 | |||
Actual Study Completion Date ICMJE | December 2014 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00556049 | |||
Other Study ID Numbers ICMJE | 07-212 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
| |||
Responsible Party | Dror Michaelson, MD, Massachusetts General Hospital | |||
Study Sponsor ICMJE | Massachusetts General Hospital | |||
Collaborators ICMJE |
| |||
Investigators ICMJE |
| |||
PRS Account | Massachusetts General Hospital | |||
Verification Date | March 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |