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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CWRU-1Y99 | |||
| NCI-G00-1859 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
Patients receive doxorubicin HCl liposome IV over 1-2.5 hours on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and vinorelbine IV over 6-10 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome, gemcitabine, and vinorelbine 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.
Patients are followed every 3 months for up to 1 year.
PROJECTED ACCRUAL: Approximately 9-24 patients will be accrued for this study within 12-18 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug | Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. | ||
| pegylated liposomal doxorubicin hydrochloride | Drug | Patients receive doxorubicin HCl liposome IV over 1-2.5 hours on day 1. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. | ||
| vinorelbine ditartrate | Drug | Patients receive vinorelbine IV over 6-10 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Beth A. Overmoyer, MD, FACP | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5055 | United States |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |