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Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma, Neoplasm Metastases

Thank you

Trial Information

Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Until disease progression

Safety Issue:

No

Principal Investigator

M. Dror Michaelson, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

07-212

NCT ID:

NCT00556049

Start Date:

December 2007

Completion Date:

December 2013

Related Keywords:

  • Renal Cell Carcinoma
  • Neoplasm Metastases
  • mRCC
  • sunitinib
  • gemcitabine
  • Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Neoplasm Metastasis

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Beth Israel Deaconess Medical Center`Boston, Massachusetts  02115