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A Phase I Trial of BMS 247550 (NSC# 710428) and Gemcitabine in Patients With Advanced Solid Tumor Malignancies

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Trial of BMS 247550 (NSC# 710428) and Gemcitabine in Patients With Advanced Solid Tumor Malignancies


- 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

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


- 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 3 months


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin at least 8.0 g/dL


- 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


- Creatinine no greater than 1.5 times ULN or 2.0 mg/dL


- 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


Biologic therapy

- At least 4 weeks since prior immunotherapy


- 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


- At least 4 weeks since prior radiotherapy

- No prior radiotherapy to more than 25% of bone marrow

- No concurrent radiotherapy


- Not specified


- 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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Sibyl Anderson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 2002

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021