UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer
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Purpose
RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with fluorouracil in treating patients who have metastatic pancreatic cancer that has not responded to treatment with gemcitabine.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: 7-hydroxystaurosporine Drug: fluorouracil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of UCN-01 in Combination With Fluorouracil in Advanced Pancreatic Cancer |
| Study Start Date: | July 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Gary K. Schwartz, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00045747 History of Changes |
| Other Study ID Numbers: | CDR0000257125, MSKCC-02049, NCI-5509 |
| Study First Received: | September 6, 2002 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the pancreas recurrent pancreatic cancer stage IV pancreatic cancer |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Fluorouracil 7-hydroxystaurosporine Staurosporine |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 13, 2013