A Phase I, Pharmacokinetic, and Treatment Duration and Escalation Study of Intravenous Intoplicine Administered as a 5 to 21-Day Continuous Infusion Every 4 Weeks
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I, Pharmacokinetic, and Treatment Duration and Escalation Study of Intravenous Intoplicine Administered as a 5 to 21-Day Continuous Infusion Every 4 Weeks
OBJECTIVES: I. Determine the intolerable dose level of intoplicine in patients with locally
advanced or metastatic cancer. II. Determine recommended phase II dose of intoplicine in
these patients. III. Determine the principal and dose limiting toxicities of intoplicine in
these patients, and determine the duration and reversibility of the toxicities. IV.
Determine the magnitude of plasma concentrations that are achieved and maintained on this
regimen and relate this parameter to toxicity outcome and antitumor activity. V. Determine
preliminary evidence of antitumor activity of intoplicine in these patients.
OUTLINE: This is a dose escalation study. The first 3 patients receive intoplicine IV by
continuous infusion for 5 days. Treatment is repeated every 28 days in the absence of
disease progression or unacceptable toxicity. Subsequent cohorts of 3-6 patients receive
escalating doses of intoplicine, first by increasing the number of days that the drug is
infused to 10, 15, and 21, then by increasing the dosage and keeping the infusion time
constant at 21 days. The intolerable dose level is defined as the lowest dose at which at
least 2 of 3 or 6 patients experience dose limiting toxicity during course 1 or 2.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven solid tumor refractory to
conventional cytotoxic anticancer therapy or for which no curative therapy exists
Measurable or evaluable disease No active, progressive brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 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 9 g/dL Hepatic: Bilirubin no greater than 1.5
mg/dL SGOT/SGPT no greater than 3 times upper limit of normal No nonmalignant hepatic
disease Renal: Creatinine no greater than 2.0 mg/dL Potassium and magnesium at least lower
limit of normal (LLN) Calcium at least LLN Cardiovascular: QTc interval on echocardiogram
less than 450 milliseconds No myocardial infarction within past 6 months No uncontrolled
congestive heart failure No unstable angina No active cardiomyopathy No unstable
ventricular arrhythmia No uncontrolled hypertension Other: Not pregnant or nursing Fertile
patients must use effective contraception Must have functional central venous access
device or percutaneous intravenous catheter No known hypersensitivity to intoplicine or
its analogs No active alcoholism or drug addiction No uncontrolled, unstable psychotic
disorders No serious infections No underlying medical conditions that may be aggravated by
treatment
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks
since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No other
concurrent antineoplastic therapy Endocrine therapy: Not specified Radiotherapy: At least
3 weeks since prior radiotherapy (except short courses (no greater than 5 fractions) of
nonmyelosuppressive, palliative radiotherapy) and recovered No concurrent radiotherapy
Surgery: Not specified Other: At least 3 weeks since prior investigational therapy No
other concurrent investigational therapy
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Gayle Cook, RN
Investigator Role:
Study Chair
Investigator Affiliation:
Genzyme
Authority:
United States: Federal Government
Study ID:
CDR0000066821
NCT ID:
NCT00003713
Start Date:
August 1997
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| San Antonio Cancer Institute | San Antonio, Texas 78229-3264 |
