Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DAIICHI-927A-PRT006 | |||
| WSU-085503MP4F |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy, such as DJ-927 and capecitabine, 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: This phase I trial is studying the side effects and best dose of DJ-927 and capecitabine in treating patients with locally advanced or metastatic solid tumors.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation, nonrandomized, multicenter study.
All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of DJ-927 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. A minimum of 6 patients receive treatment at the MTD.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 18 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DJ-927 | Drug | |||
| capecitabine | Drug |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor
Minimally pretreated
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Recovered from prior radiotherapy
No concurrent anticancer radiotherapy
Surgery
Other
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chris H. Takimoto, MD, PhD, FACP | Cancer Therapy and Research Center, Texas |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham | Alabama | 35294-3300 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21547572 | Result | Saif MW, Sarantopoulos J, Patnaik A, Tolcher AW, Takimoto C, Beeram M. Tesetaxel, a new oral taxane, in combination with capecitabine: a phase I, dose-escalation study in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2011 Dec;68(6):1565-73. doi: 10.1007/s00280-011-1639-3. Epub 2011 May 6. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C479543 | tesetaxel |
| D000069287 | Capecitabine |
| 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
Not provided
| Barbara Ann Karmanos Cancer Institute |
| Detroit |
| Michigan |
| 48201-1379 |
| United States |
| Cancer Therapy and Research Center | San Antonio | Texas | 78229 | United States |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |