BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 combining BMS-247550 with gemcitabine in treating patients who have advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: gemcitabine hydrochloride Drug: ixabepilone |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of BMS 247550 (NSC# 710428) and Gemcitabine in Patients With Advanced Solid Tumor Malignancies |
| Study Start Date: | June 2002 |
OBJECTIVES:
- Determine the maximum tolerated dose, dose-limiting toxicity, and safety of BMS-247550 when combined with gemcitabine in patients with advanced solid tumors.
- Determine the plasma pharmacokinetics of this regimen in this patient population.
- Assess, preliminarily, any antitumor activity of this regimen in this patient population.
OUTLINE: This is a dose-escalation study of BMS-247550.
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by BMS-247550 IV over 3 hours on day 8. The order of chemotherapy drug administration on day 8 is reversed during the second course only. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 9 patients total are treated at the MTD.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-hematological cancer that is unresponsive to currently available therapies or for which there is no known effective treatment
- Clinical or radiological evidence of disease required
- No active brain metastases, including evidence of cerebral edema (by CT scan or MRI), progression from prior imaging study, any requirement for steroids, or clinical symptoms
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin at least 8.0 g/dL
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- ALT and AST no greater than 2.5 times upper limit of normal (ULN) or 93 U/L
Renal
- Creatinine no greater than 1.5 times ULN or 2.0 mg/dL
Other
- No documented hypersensitivity reaction to prior paclitaxel or other therapy containing Cremophor EL
- No grade 2 or greater pre-existing peripheral neuropathy
- No serious uncontrolled medical disorder or active infection that would preclude study therapy
- No dementia or altered mental status that would preclude informed consent
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior immunotherapy
Chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome)
- Prior taxanes allowed
- Prior adjuvant or neoadjuvant chemotherapy allowed
- No more than 2 prior chemotherapy regimens in the metastatic setting
- No other concurrent chemotherapy
Endocrine therapy
- See Disease Characteristics
- No concurrent hormonal therapy except hormone-replacement therapy
- Concurrent medications to maintain castrate status for progressive hormone-refractory prostate cancer allowed
Radiotherapy
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of bone marrow
- No concurrent radiotherapy
Surgery
- Not specified
Other
- At least 4 weeks since prior investigational agents
- No other concurrent experimental anticancer medications
- No concurrent alternative therapies (e.g., high-dose vitamins or herbal medicines)
- No concurrent combination antiretroviral therapy for HIV-positive patients
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Sibyl Anderson, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00043095 History of Changes |
| Other Study ID Numbers: | CDR0000256333, MSKCC-02012, NCI-5696 |
| Study First Received: | August 5, 2002 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Gemcitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 21, 2013