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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.

- 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 CenterLebanon, New Hampshire  03756-0002