Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma
Status: | Completed |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/1/2014 |
Start Date: | December 2007 |
End Date: | December 2013 |
Contact: | Carol Gurski, RN |
Email: | cgurski@partners.org |
Phone: | 617-643-1770 |
Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma
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.
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.
- Participants will receive study treatment as an outpatient. Study treatment will be
given in 3-week cycles.
- Sunitinib will be taken orally once per day for the first two weeks (days 1-14) of each
treatment cycle.
- Gemcitabine will be given intravenously at the study clinic on days 1 and 8 of each
treatment cycle.
- Before receiving sunitinib and gemcitabine on day 1 of each cycle the following will be
performed: physical exam, performance status assessment and blood work. Before
receiving gemcitabine on day 8 the following will be performed: physical exam,
performance status assessment and blood work. Every 3 cycles a CT scan will be
performed to measure the tumor.
given in 3-week cycles.
- Sunitinib will be taken orally once per day for the first two weeks (days 1-14) of each
treatment cycle.
- Gemcitabine will be given intravenously at the study clinic on days 1 and 8 of each
treatment cycle.
- Before receiving sunitinib and gemcitabine on day 1 of each cycle the following will be
performed: physical exam, performance status assessment and blood work. Before
receiving gemcitabine on day 8 the following will be performed: physical exam,
performance status assessment and blood work. Every 3 cycles a CT scan will be
performed to measure the tumor.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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