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Phase II Study of UCN-01 in Combination With Fluorouracil in Advanced Pancreatic Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

Phase II Study of UCN-01 in Combination With Fluorouracil in Advanced Pancreatic Cancer


OBJECTIVES:

- Determine the response rate, time to progression, and overall survival of patients with
gemcitabine-refractory metastatic pancreatic cancer treated with UCN-01 and
fluorouracil.

- Determine the toxicity of this regimen in these patients.

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.

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

Inclusion 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

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/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 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

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Gary K. Schwartz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000257125

NCT ID:

NCT00045747

Start Date:

July 2002

Completion Date:

September 2004

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021