Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01CA062502 | U.S. NIH Grant/Contract | View source | |
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CWRU-5Y99 | Other Identifier | Case Comprehensive Cancer Center | |
| NCI-370 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.
OBJECTIVES:
OUTLINE: This is a dose-escalation study of irinotecan and capecitabine.
Patients receive oxaliplatin IV over 2 hours followed 1 hour later by irinotecan IV over 30 minutes once weekly for 4 weeks. Patients also receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 9-15 patients will be accrued for this study within 9-15 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine | Drug | Patients receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose(MTD). | ||
| irinotecan hydrochloride | Drug | Patients receive irinotecan IV over 30 minutes once weekly for 4 weeks (one hour after oxaliplatin). Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose(MTD). |
| |
| oxaliplatin | Drug | Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors. | Treatment cycle is four weeks, repeated every six weeks in the absence of disease progression or unacceptable toxicity. |
Not provided
Not provided
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Scot C. Remick, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18414865 | Result | Krishnamurthi SS, Brell JM, Hoppel CL, Egorin MJ, Weaver KC, Li X, Ingalls ST, Zuhowski EG, Schluchter MD, Dowlati A, Cooney MM, Gibbons J, Overmoyer BA, Ivy SP, Remick SC. Phase I clinical and pharmacokinetic study of oxaliplatin, irinotecan and capecitabine. Cancer Chemother Pharmacol. 2009 Feb;63(3):441-50. doi: 10.1007/s00280-008-0754-2. Epub 2008 Apr 15. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077146 | Irinotecan |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |