Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Bayer |
---|---|
Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00613145 |
This is a phase I, randomized, safety and pharmacokinetic (PK) study of sorafenib given in combination with capecitabine. The study will enroll two simultaneous cohorts; patients will be randomly assigned to either Cohort A or Cohort B. A third cohort (C) may be added to the protocol at a later date.
Condition | Intervention | Phase |
---|---|---|
Refractory Malignancy |
Drug: Capecitabine and Sorafenib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | A Phase I Pharmacokinetic and Safety Study of Sorafenib + Capecitabine in Advanced Solid Tumors |
Estimated Enrollment: | 36 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Treatment with Capecitabine and Sorafenib
|
Drug: Capecitabine and Sorafenib
During Cycle 1, patients will receive capecitabine alone for the first 7 days (Cohort A will receive 750 mg/m2 of capecitabine twice daily). For Days 8-14 of Cycle 1, patients will receive capecitabine (750 mg/m2 twice daily for Cohort A) combined with sorafenib (400 mg twice daily); on Days 15-21 of Cycle 1, patients will receive sorafenib alone (400 mg twice daily). Beginning with Day 1 of Cycle 2 and all treatment cycles thereafter, patients will be dosed as follows: Cohort A will receive sorafenib orally at 400 mg twice daily for 21 days, and capecitabine orally at 750 mg/m2 twice daily for the first 14 days of a 21-day treatment cycle. |
B: Active Comparator
Treatment with Capecitabine and Sorafenib
|
Drug: Capecitabine and Sorafenib
During Cycle 1, patients will receive capecitabine alone for the first 7 days Cohort B will receive 1000 mg/m2 of capecitabine twice daily for the first 7 days of Cycle 1). For Days 8-14 of Cycle 1, patients will receive capecitabine (1000 mg/m2 twice daily for Cohort B) combined with sorafenib (400 mg twice daily for both cohorts); on Days 15-21 of Cycle 1, patients will receive sorafenib alone (400 mg twice daily). Beginning with Day 1 of Cycle 2 and all treatment cycles thereafter, patients will be dosed as follows: Cohort B will receive sorafenib orally at 400 mg twice daily for 21 days, and capecitabine orally at 1000 mg/m2 twice daily for the first 14 days of a 21-day treatment cycle.
|
During Cycle 1, patients will receive capecitabine alone for the first 7 days (Cohort A will receive 750 mg/m2 of capecitabine twice daily, and Cohort B will receive 1000 mg/m2 of capecitabine twice daily for the first 7 days of Cycle 1). For days 8-14 of Cycle 1, patients will receive capecitabine (750 mg/m2 twice daily for Cohort A; 1000 mg/m2 twice daily for Cohort B) combined with sorafenib (400 mg twice daily for both cohorts); on days 15-21 of Cycle 1, patients will receive sorafenib alone (400 mg twice daily for both cohorts). Beginning with day 1 of Cycle 2 and all treatment cycles thereafter, patients will be dosed as follows: Cohort A will receive sorafenib orally at 400 mg twice daily for 21 days, and capecitabine orally at 750 mg/m2 twice daily for the first 14 days of a 21-day treatment cycle.
Cohort B will receive sorafenib orally at 400 mg twice daily for 21 days, and capecitabine orally at 1000 mg/m2 twice daily for the first 14 days of a 21-day treatment cycle. After 6 patients each are enrolled into Cohort A and Cohort B, one of these two cohorts will enroll an additional 6-12 patients in an expansion phase.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, liver, and renal function as assessed by the following:
Exclusion Criteria:
Contact: Jeffrey Infante, M.D. | (615) 329-7274 | jinfante@tnonc.com |
Contact: Trials Info | (615) 329-7274 | trialsinfo@scresearch.net |
United States, Tennessee | |
Tennessee Oncology, PLLC | Recruiting |
Nashville, Tennessee, United States, 37023 |
Study Chair: | Jeffrey Infante, M.D. | SCRI Oncology Research Consortium |
Responsible Party: | SCRI Oncology Research Consortium ( Jeffrey Infante, M.D. ) |
Study ID Numbers: | SCRI REFMAL 122 |
Study First Received: | January 17, 2008 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00613145 |
Health Authority: | United States: Institutional Review Board |
Refractory Malignancy Phase I Sorafenib Capecitabine |
Capecitabine Fluorouracil Sorafenib |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Immunosuppressive Agents Pharmacologic Actions |