A Phase I Trial of BMS 247550 (NSC# 710428) and Gemcitabine in Patients With Advanced Solid Tumor Malignancies
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Trial of BMS 247550 (NSC# 710428) and Gemcitabine in Patients With Advanced Solid Tumor Malignancies
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Sibyl Anderson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000256333
NCT ID:
NCT00043095
Start Date:
June 2002
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
