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Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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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 CenterLebanon, New Hampshire  03756
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Medical GroupPasadena, California  91105