NCT00496223

A Phase I/II Study of Sunitinib and Dacarbazine

A Phase I/II Study of Sunitinib and Dacarbazine in Patients With Metastatic Melanoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a combination Phase I/II design that explores the toxicity and activity of Sunitinib and Dacarbazine (DTIC) for metastatic melanoma. The initial Phase I part of this trial will consist of a dose escalation of sunitinib while keeping the DTIC dose constant. If no DLT is seen, this dose will be the suggested Phase II trial dose. If less than 2 disease responses are seen, patients will not be enrolled any further, and the study will be considered negative for activity. If a clinical response is seen, patients will continue to be enrolled.

Detailed description

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Sunitinib	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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2007-07-04
• Last updated: 2011-02-23

Locations

1 site across 1 country: United States