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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000434850 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-6868 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy, such as vorinostat and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat and capecitabine in treating patients with unresectable or metastatic solid tumors.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral vorinostat (SAHA) once or twice daily and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses beyond documentation of CR. Patients achieving a partial response receive 2 courses beyond documentation of best response.
Cohorts of 3-6 patients receive escalating doses of SAHA 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. An additional 12 patients are treated at the MTD.
After completion of study treatment, patients are followed at 3-4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: Approximately 18-30 patients will be accrued for this study within 6-10 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAHA (Suberoylanilide Acid) with Capecitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine | Drug |
| ||
| vorinostat |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated doses of vorinostat (SAHA) and capecitabine | 1 cycle | |
| Safety and tolerability as assessed by CTCAE v3.0 | All cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate as assessed by RECIST criteria | Every 2 cycles | |
| Molecular markers as assessed by molecular analysis | Cycle 1 | |
| Survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed malignant solid tumor
Standard curative or palliative measures do not exist or are no longer effective
Patients who received prior radiotherapy must have measurable disease outside a previously irradiated field OR disease progression after prior radiotherapy
No known brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Eric X. Chen, MD, PhD | Princess Margaret Hospital, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital Regional Cancer Centre - General Campus | Ottawa | Ontario | K1H 8L6 | Canada | ||
| Princess Margaret Hospital |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077337 | Vorinostat |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Drug |
|
| progression free survival every 2 cycles |
| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |