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A Phase 2 Study Of UCN-01 In Advanced Renal Cell Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

A Phase 2 Study Of UCN-01 In Advanced Renal Cell Carcinoma


OBJECTIVES:

- Determine the efficacy of UCN-01, in terms of time to objective progression, in
patients with stage IV or unresectable stage III renal cell carcinoma.

- Determine the objective response rate in patients treated with this drug.

OUTLINE: Patients receive UCN-01 IV over 3 hours on day 1. Courses repeat every 3 weeks in
the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 21-61 patients will be accrued for this study within 15
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed stage IV or unresectable stage III renal
cell carcinoma

- Metastatic disease must be amenable to biopsy or appropriate for nephrectomy
before study therapy

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- No known prior or concurrent CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy:

- More than 3 months

Hematopoietic:

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin normal

- AST/ALT no greater than 2.5 times upper limit of normal

Renal:

- Creatinine normal OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No history of clinically significant coronary artery disease

- No symptomatic cardiac dysfunction

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Pulmonary:

- No symptomatic pulmonary dysfunction

Other:

- No prior allergic reactions to compounds of similar chemical or biological
composition to UCN-01

- No other uncontrolled concurrent illness

- No active or ongoing infection

- No known immune deficiency

- No psychiatric illness or social situation that would preclude study compliance

- No insulin-dependent diabetes mellitus

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 4 weeks since prior radiotherapy and recovered

- No prior mediastinal radiation

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior nephrectomy

Other:

- No more than 2 prior systemic therapies for metastatic renal cell carcinoma

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Brian I. Rini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000069208

NCT ID:

NCT00030888

Start Date:

December 2002

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
UCSF Comprehensive Cancer CenterSan Francisco, California  94115