Imatinib Mesylate, Gemcitabine, and Capecitabine in Treating Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

August 15, 2006

Primary Completion Date

January 30, 2009

Study Completion Date

March 29, 2011

Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
DRUG

capecitabine

"Dose level Capecitabine~-1 400 mg/m2 bid~0 500 mg/m2 bid~1. 500 mg/m2 bid~2. 600 mg/m2 bid~3. 600 mg/m2 bid~4. 725 mg/m2 bid~5. 725 mg/m2 bid~6. 850 mg/m2 bid~7. 850 mg/m2 bid"

DRUG

gemcitabine hydrochloride

"Dose level Gemcitabine~-1 400 mg/m2 0 450 mg/m2~1. 550 mg/m2~2. 550 mg/m2~3. 675 mg/m2~4. 675 mg/m2~5. 825 mg/m2~6. 825 mg/m2~7. 1000 mg/m2"

DRUG

imatinib mesylate

"Dose level Imatinib~-1 400 mg/d 0 400 mg/d~1. 400 mg/d~2. 400 mg/d~3. 400 mg/d~4. 400 mg/d~5. 400 mg/d~6. 400 mg/d~7. 400 mg/d"

GENETIC

mutation analysis

C-kit mutations will be assessed on existing paraffin-embedded blocks by Polymerase Chain Reaction and direct sequencing of both juxtamembrane domains (exons 9 and 11) and the tyrosine kinase domain (exons 13 and 17). Every ABI sequence will be compared to a NCBI Human KIT gene nucleotide sequence and will be blast using a NCBI Standard Nucleotide Blast Search to determine the presence of mutation within a particular exon.

GENETIC

nucleic acid sequencing

C-kit mutations will be assessed on existing paraffin-embedded blocks by Polymerase Chain Reaction and direct sequencing of both juxtamembrane domains (exons 9 and 11) and the tyrosine kinase domain (exons 13 and 17). Every ABI sequence will be compared to a NCBI Human KIT gene nucleotide sequence and will be blast using a NCBI Standard Nucleotide Blast Search to determine the presence of mutation within a particular exon.

GENETIC

polymerase chain reaction

C-kit mutations will be assessed on existing paraffin-embedded blocks by Polymerase Chain Reaction and direct sequencing of both juxtamembrane domains (exons 9 and 11) and the tyrosine kinase domain (exons 13 and 17). Every ABI sequence will be compared to a NCBI Human KIT gene nucleotide sequence and will be blast using a NCBI Standard Nucleotide Blast Search to determine the presence of mutation within a particular exon.

Trial Locations (1)

68198-6805

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

University of Nebraska

OTHER

NCT00483366 - Imatinib Mesylate, Gemcitabine, and Capecitabine in Treating Patients With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter