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Phase I and Pharmacokinetics Study of SarCNU in Patients With Advanced Cancers

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

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Trial Information

Phase I and Pharmacokinetics Study of SarCNU in Patients With Advanced Cancers

OBJECTIVES: I. Determine the maximum tolerated dose of SarCNU in patients with advanced
solid malignancies. II. Determine the toxic effects of SarCNU in these patients. III.
Characterize the pharmacokinetic profile of this regimen in these patients. IV. Determine
any evidence of antineoplastic activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study. Patients receive oral SarCNU on days 1, 5, and 9.
Treatment continues every 4 weeks in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of SarCNU 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 treated at the MTD.

PROJECTED ACCRUAL: Approximately 12-36 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced solid malignancy for which no
curative or life-extending therapy exists No prior or concurrent CNS metastases Primary
CNS tumors allowed if on a stable dose of steroids at least 2 weeks before study entry No
myelodysplastic syndrome

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
More than 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3
Platelet count greater than 120,000/mm3 Hemoglobin greater than 8 g/dL Hepatic: Bilirubin
normal AST and ALT less than 2.5 times upper limit of normal Renal: Creatinine less then
1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No uncontrolled
cardiac disease No uncontrolled hypertension Pulmonary: DLCO and vital capacity greater
than 80% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception HIV negative Oral intake at least 1,200 calories per day
No recent weight loss of more than 10% actual body weight No serious concurrent illness No
uncontrolled infection

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
No concurrent immunotherapy No concurrent immunomodulating agents Chemotherapy: At least 4
weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent
cytostatic or cytotoxic chemotherapy Endocrine therapy: See Disease Characteristics No
concurrent hormonal therapy No concurrent dexamethasone Radiotherapy: At least 3 weeks
since prior radiotherapy No prior radiotherapy to more than 25% of bone marrow No
concurrent radiotherapy Surgery: At least 3 weeks since prior major surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Lawrence C. Panasci, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jewish General Hospital


United States: Federal Government

Study ID:




Start Date:

January 1999

Completion Date:

March 2004

Related Keywords:

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