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BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors
This study has been completed.
First Received: August 10, 2001   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Fox Chase Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022529
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of BMS-214662 plus trastuzumab in treating patients who have advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Biological: trastuzumab
Drug: BMS-214662
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Trastuzumab BMS 214662
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Intravenous BMS-214662 FTI (NSC# 710086) and Herceptin (NSC# 688097) Weekly in Patients With Advanced Malignancies

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2001
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose and recommended phase II dose of BMS-214662 when combined with trastuzumab (Herceptin) in patients with advanced solid tumors.
  • Determine the dose-limiting toxic effects of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Determine, in a preliminary manner, the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of BMS-214662.

Patients receive BMS-214662 IV over 1 hour on days 2, 8, 15, and 22 and trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with BMS-214662 and trastuzumab at the recommended phase II dose.

PROJECTED ACCRUAL: A total of 3-28 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
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective therapy exists
  • Overexpressing HER-2-neu (2+ or 3+) by immunohistochemistry or fluorescent in situ hybridization
  • Clinically or radiologically evaluable disease
  • No carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease

    • At least 8 weeks since prior therapy for prior brain parenchymal disease and asymptomatic off corticosteroids

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.8 mg/dL
  • ALT and AST no greater than 1.5 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No uncontrolled or significant cardiovascular disease
  • No myocardial infarction within the past 6 months
  • No prior clinically significant atrial or ventricular arrhythmias
  • No prior second or third degree heart block
  • No ischemic heart disease requiring medication
  • No congestive heart failure
  • Corrected QT interval no greater than 450 milliseconds by electrocardiogram
  • Ejection fraction at least lower limit of normal by MUGA scan

Pulmonary:

  • No uncontrolled or significant pulmonary disease

Other:

  • No active unresolved infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy, including trastuzumab (Herceptin), and recovered

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No anthracyclines for at least 22 weeks after completion of study therapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • Concurrent hormone replacement therapy allowed
  • No other concurrent hormonal therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of the bone marrow-containing skeleton
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • At least 4 weeks since prior investigational agents and recovered
  • At least 7 days since prior known substrates of cytochrome P450-3A4 (CYP3A4)
  • At least 7 days since prior parenteral antibiotics
  • No concurrent substrates of CYP3A4
  • No concurrent parenteral antibiotics
  • No other concurrent experimental medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022529

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: Mary Cianfrocca, DO Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068828, FCCC-01013, NCI-139
Study First Received: August 10, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00022529     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Trastuzumab

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Trastuzumab
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009