A Phase I/II Study of Sunitinib and Dacarbazine
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Sunitinib and Dacarbazine in Patients With Metastatic Melanoma|
- To determine the toxicity and safety of this combination and determine the recommended Phase II dose of this combination. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To determine the overall response rate of the combination of sunitinib and DTIC as the first line treatment in stage IV malignant melanoma. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- To determine the progression free survival (PFS) of disease of patients treated with the combination of sunitinib and DTIC. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To determine Overall Survival of patients treated with this combination. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2006|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Sunitinib will be given PO once daily on days 1-14 of each 21 day cycle. The exact dose of sunitinib will be determined during the Phase I part of the trial.Drug: Dacarbazine
Dacarbazine will be given at 1000 mg/m2 on day 1 of every 21 day cycle.
Other Name: DTIC
This is a combination Phase I/II design that explores the toxicity and activity of a combination of sunitinib and Dacarbazine (DTIC) for metastatic melanoma. Screening tests (pre-study) will consist of a history, physical, CBC, CMP, EKG, pregnancy test for women of childbearing age, amylase (blood test for diagnoses of pancreatitis or other pancreatic diseases), staging CT, and PK. Also, on day 1, these tests will be repeated - a history, physical, toxicity assessment, CBC, and amylase test. Re-staging tests will be performed after 2 complete cycles and follow up as indicated clinically.
The initial Phase I part of this trial will consist of a dose escalation of sunitinib while keeping the DTIC dose constant. Sunitinib will be given 2 weeks on and 1 week off with DTIC given once every 21 days for one cycle. If no DLT is seen, the maximum tolerated sunitinib dose will be the suggested as the Phase II trial dose.
Tumor response will be measured after 2 complete cycles. Subsequently, during Phase II the trial will enroll more patients; if less than 2 responses are seen, patients will not be enrolled any further, and the study will be considered negative for activity. But, if a clinical response is seen, more patients will be enrolled at the Phase II dose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496223
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Adil Daud, M.D.||UCSF (formerly at H. Lee Moffitt Cancer Center & Research Institute)|