A Phase I/II Study of Dasatinib and Dacarbazine in Patients With Metastatic Melanoma
Patient will receive Dacarbazine intravenously (IV), which means it is given through a
needle in a vein in the arm or through a venous port (if patient already has one). Dasatinib
will be given orally starting day 2 for 17 days straight (days 2 through 19) starting the
day after patient receives their first dose of Dacarbazine. The therapy will be repeated
every 21 days (21 days = 1 cycle). Patient may be given other drugs before each cycle to
help reduce side effects of the therapy. If patient experiences severe side effects, the
amount of Dacarbazine and/or Dasatinib they receive in future cycles may be decreased.
Cycle 1 day 1:
- Dacarbazine Intravenous
- Toxicity assessment - evaluation of any side effects that patient may be experiencing
- Medical history*
- Physical examination* - measure height, weight, blood pressure, pulse, breathing rate,
temperature, assessment of patient's energy and activity level (Eastern Cooperative
Group [ECOG] Performance Status)
- Blood tests (3 tablespoons) for safety tests*- Complete blood count with differential
and platelets (CBC), Comprehensive metabolic profile (CMP), & Magnesium test *(certain
tests may not need to be performed if they were performed during screening within 1
week; study doctor will tell patient if they need to have these tests redone)
Cycle 1 day 8:
- Toxicity assessment - (these will be done for the first cycle of treatment, but will be
discontinued for later cycles unless deemed necessary by study doctor)
- CBC - (1 tablespoon) (this will be done for the first cycle of treatment, but will be
discontinued for later cycles unless deemed necessary by study doctor)
- Dasatinib orally
Cycle 1 day 15:
- Toxicity assessment - (these will be done for the first cycle of treatment, but will be
discontinued for later cycles unless deemed necessary by study doctor)
- CBC - (1 tablespoon) these will be done for the first cycle of treatment, but will be
discontinued for later cycles unless deemed necessary by study doctor)
- Dasatinib orally
- Blood sample for pharmacokinetic (PK) analysis
Patient will also take Dasatinib orally as instructed days: 2, 3, 4, 5, 6, 7, 9, 10, 11, 12,
13, 14, 16, 17, 18, 19 each cycle.
Day 1 for all cycles after the first cycle:
- Dacarbazine Intravenous (IV)
- Dasatinib orally
- Medical history
- Physical examination: measure height, weight, blood pressure, pulse, breathing rate,
temperature, assessment of patient's energy and activity level (ECOG Performance
Status)
- Blood tests (2 tablespoon) for safety tests: CMP & CBC
- An electrocardiogram (EKG)
- Computed tomography (CT) scan (done every other cycle starting with cycle 2)
- Toxicity assessment
If patient decides not to continue participation in this study or is taken off the study by
their study doctor or the sponsor they will return to the clinic for one more visit.
During this visit the following procedures will be performed:
- Medical history
- Perform a physical examination: measure height, weight, blood pressure, pulse,
breathing rate, temperature, assessment of patient's energy and activity level (Eastern
Cooperative Group [ECOG] Performance Status)
- Blood tests (2 tablespoons) for safety tests: CBC & CMP
- Toxicity assessment Patient will need to take their assigned Dasatinib dose twice
daily. It may be taken with or without food.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended Phase II Dose
To determine the maximum tolerated dose of dasatinib twice a day when given with dacarbazine. Adverse events were graded using Common Terminology Criteria for Adverse Events version 3.0. Dose-limiting toxicities are defined as any grade 4 haematological toxicity (except asymptomatic grade 4 neutropenia for =/< 7 days); prolonged grade 3 or 4 thrombocytopenia (47 days) or thrombocytopenia associated with bleeding, requiring platelet transfusion; any grade 3 or 4 nonhaematological toxicity despite optimal supportive care; any toxicity considered unacceptable by the study principal investigator.
1 Year 3 Months
No
Jeffrey Weber, M.D.. Ph.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
MCC-15256
NCT00597038
November 2007
September 2011
Name | Location |
---|---|
H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco | San Francisco, California 94115 |