Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI MSKCC-02049 NCI-5509, 5509, NCT00045747

Objectives

1. Determine the response rate, time to progression, and overall survival of patients with gemcitabine-refractory metastatic pancreatic cancer treated with UCN-01 and fluorouracil.
2. Determine the toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Progressive disease after gemcitabine-based chemotherapy for metastatic disease



• At least 1 unidimensionally measurable metastatic lesion
  • At least 20 mm by conventional techniques OR
  • At least 10 mm by spiral CT scan
  • Primary disease site is not considered a measurable lesion



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent immunotherapy

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No more than 1 prior chemotherapy regimen for metastatic or recurrent disease
• No prior fluorouracil in the adjuvant or inoperable, locally advanced setting (except as a radiosensitizer)
• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy and recovered
• No prior mediastinal irradiation
• No concurrent radiotherapy

Surgery

• Not specified

Other

• No prior UCN-01 or other cyclin-dependent kinase inhibitors
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational or commercial anticancer agents or therapies
• No concurrent anticonvulsant medications

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

  OR

• Karnofsky 70-100%

Life expectancy

• More than 8 weeks

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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 symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac tachyarrhythmia

Pulmonary

• No symptomatic chronic obstructive pulmonary disease
• No pulmonary embolism within the past 6 months

Other

• No prior allergic reactions to compounds of similar chemical or biological composition to UCN-01 or other agents used in this study
• No diabetes mellitus uncontrolled by insulin or oral hypoglycemic agents
• No uncontrolled concurrent illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception before, during, and for 3 months after study

Expected Enrollment

A total of 12-37 patients will be accrued for this study within 3-13 months.

Outline

Patients receive fluorouracil IV over 24 hours on days 1, 8, 15, and 22. Patients also receive UCN-01 IV continuously over 72 hours (course 1 only) beginning on day 2. In subsequent courses, UCN-01 is infused over 36 hours. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Gary K. Schwartz, MD, Protocol chair		Ph: 212-639-8324; 800-525-2225

Registry Information
Official Title		Phase II Study of UCN-01 in Combination with Fluorouracil in Advanced Pancreatic Cancer
Trial Start Date		2002-07-16
Registered in ClinicalTrials.gov		NCT00045747
Date Submitted to PDQ		2002-07-19
Information Last Verified		2004-08-11
NCI Grant/Contract Number		N01-CM17105, P30-CA08748

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