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Phase I Dose Finding Study of Anhydrovinblastine Administered as a 1-Hour Infusion Every 3 Weeks to Patients With Advanced Solid Tumors

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

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Trial Information

Phase I Dose Finding Study of Anhydrovinblastine Administered as a 1-Hour Infusion Every 3 Weeks to Patients With Advanced Solid Tumors

OBJECTIVES: I. Determine the maximum tolerated dose and assess the toxicity of
anhydrovinblastine in patients with advanced refractory solid tumors. II. Assess the safety,
pharmacokinetics, and efficacy of this treatment regimen in this patient population.

OUTLINE: This is a dose escalation study. Patients receive anhydrovinblastine IV over 1 hour
on day 1. Courses are repeated every 3 weeks. Treatment continues in the absence of disease
progression or unacceptable toxicity. The dose of anhydrovinblastine is escalated in cohorts
of 1-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as
the dose that at which no more than 2 of 6 patients experience dose limiting toxicity.
Patients are followed at 1 month after treatment, and then monthly until death.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 8 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor unresponsive to
existing therapy and for which no curative therapy exists No hematologic malignancies

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: SGOT and SGPT no greater than
2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN
(except with bone metastases) PT and PTT no greater than ULN Bilirubin no greater than ULN
Renal: Creatinine no greater than ULN OR Creatinine clearance at least 60 mL/min
Cardiovascular: No congestive heart failure, angina pectoris (even if medically
controlled), uncontrolled hypertension, arrhythmias, elevated CPK or recent EKG changes At
least one year since myocardial infarction Neurologic: No history of neurologic or
psychiatric disorders (e.g., dementia, seizures) No concurrent peripheral neuropathy
greater than grade 1 Other: Not pregnant or nursing Fertile patients must use effective
contraception No active infection No active pancreatitis Amylase no greater than the upper
limit of normal No other serious systemic disease

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
and recovered No concurrent immunotherapy No concurrent colony stimulating factors (unless
evidence of neutropenic infection) Chemotherapy: At least 4 weeks since prior chemotherapy
(6 weeks for nitrosourea or mitomycin) Prior taxanes and vinca alkaloids allowed with
recovery (excluding alopecia any grade and peripheral neuropathy no greater than grade 1)
No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4
weeks since prior radiotherapy and recovered At least 6 weeks since prior extensive
radiotherapy to greater than 20% of bone marrow No concurrent radiotherapy Surgery: Not
specified Other: No other concurrent experimental drugs At least 30 days since other
investigational drug

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Nithya Ramnath, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 1999

Completion Date:

September 2000

Related Keywords:

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



Roswell Park Cancer Institute Buffalo, New York  14263