Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors
OBJECTIVES:
- Determine the maximum tolerated dose of cisplatin when administered with UCN-01 in
patients with advanced solid tumors.
- Assess the toxicity and potential antitumor activity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study of cisplatin.
Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72
hours beginning on day 2. Treatment continues every 4 weeks for a total of 6 courses in the
absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of cisplatin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Patients are followed every 2-3 months for at least 1 year.
PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced or metastatic solid tumor
incurable by surgery or other standard therapy
- Tumor site accessible by biopsy
- No brain metastasis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC at least 4,500/mm3
- Absolute neutrophil count at least 2,000/mm3
- Platelet count at least 150,000/mm3
Hepatic:
- Bilirubin normal
- SGOT no greater than 2.5 times upper limit of normal
Renal:
- Creatinine normal
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No New York Heart Association class III or IV congestive heart failure
Other:
- No peripheral neuropathy greater than grade I
- No history of allergic reactions to diuretics or antiemetics (e.g., 5-HT3
antagonists) that would preclude study
- No other uncontrolled illness that would preclude study, including intolerance to
vigorous hydration
- No medical, social, or psychological factors that would preclude study
- 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:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and
recovered
- No greater than 2 prior chemotherapy regimens
- Prior cisplatin allowed if cumulative dose no greater than 400 mg/m2
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from any prior surgery
Other:
- At least 30 days since prior investigational drugs
- No other concurrent investigational drugs
- No other concurrent anticancer agents
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
David R. Gandara, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, Davis
Authority:
United States: Federal Government
Study ID:
CDR0000068274
NCT ID:
NCT00006464
Start Date:
March 2001
Completion Date:
June 2008
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| City of Hope Medical Group | Pasadena, California 91105 |
