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.
- Determine 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 study of cisplatin.
Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72
hours on day 2. Treatment repeats every 4 weeks for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 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 12-18
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced or metastatic solid tumor that is
not amenable to standard therapy
- No brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC at least 4,000/mm^3
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 150,000/mm^3
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 coronary artery disease
- No New York Heart Association class III or IV heart disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
- Must have central indwelling venous catheter
- No peripheral neuropathy greater than grade 1
- No prior allergic reaction to diuretics or antiemetics (e.g., 5-HT3 antagonists) to
be administered during study
- No clinically significant hearing loss
- No uncontrolled concurrent illness that would preclude study therapy
- No medical, social, or psychological factor that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No more than 2 prior chemotherapy regimens
- At least 4 weeks since prior chemotherapy (at least 6 weeks for mitomycin or
nitrosoureas) and recovered
- Prior cumulative dose of cisplatin no greater than 250 mg/m^2
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to the mediastinum
- No concurrent radiotherapy
Surgery:
- Recovered from prior surgery
Other:
- At least 30 days since prior investigational drugs
- No other concurrent investigational drugs
- No other concurrent anti-cancer agents
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose (MTD).
Outcome Description:
To establish the maximum tolerated dose (MTD) of cisplatin in combination with UCN-01 in patients with advanced malignancies.
Outcome Time Frame:
Cycle 1 (28 days)
Safety Issue:
Yes
Principal Investigator
Raymond P. Perez, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Norris Cotton Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000068492
NCT ID:
NCT00012194
Start Date:
March 2001
Completion Date:
January 2007
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
