UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of combining UCN-01 with gemcitabine in treating patients who have unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may help gemcitabine kill more cancer cells by making tumor cells more sensitive to the drug

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: 7-hydroxystaurosporine; Gemcitabine; Staurosporine

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the pancreas

• Unidimensionally measurable disease

• At least 20 mm by conventional techniques

• At least 10 mm by spiral CT scan

• Tumor lesions in a previously irradiated area are not considered measurable

• No known brain metastases

• Patients with signs or symptoms of CNS metastasis at any time during screening must have a negative CT scan or MRI of the brain

• Performance status - ECOG 0-2

• Performance status - Karnofsky 60-100%

• More than 3 months

• WBC at least 3,000/mm^3

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

• Platelet count greater than 100,000/mm^3

• Bilirubin no greater than 1.5 mg/dL

• ALT and AST no greater than 2.5 times upper limit of normal

• Creatinine normal

• Creatinine clearance at least 60 mL/min

• No prior coronary artery disease

• No symptomatic cardiac dysfunction

• No prior myocardial infarction

• No active angina (even if controlled by medication)

• No positive stress test

• No uncontrolled arrhythmia

• Left ventricular ejection fraction at least 45%

• Patients with symptoms suggestive of coronary artery disease or arrhythmia must have no evidence of cardiac pathology

• No symptomatic pulmonary dysfunction

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

• No prior allergic reactions attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents

• No insulin-dependent diabetes mellitus

• No other concurrent uncontrolled illness

• No ongoing or active infections

• No concurrent psychiatric illness

• No other active malignancy

• No other solid tumor within the past 5 years except neoplasia in situ or nonmelanomatous skin cancer

• No social situations that would preclude study compliance

• No concurrent over-the-counter biologics

• No concurrent growth factors during the first study course

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

• No more than 2 prior chemotherapy regimens (e.g., gemcitabine and/or experimental agents) alone or in combination with radiotherapy as neoadjuvant or adjuvant therapy for resectable, unresectable, or metastatic disease

• See Chemotherapy

• At least 6 weeks since prior radiotherapy and recovered

• Prior radiotherapy directed only at the primary tumor bed allowed

• No prior radiotherapy to the mediastinum, pelvis, lower spine, or more than 20% of bone marrow

• At least 4 weeks since prior major surgery

• At least 4 weeks since prior investigational agents

• Concurrent enrollment in non-therapy trials (e.g., quality of life) allowed

• No concurrent herbal remedies

• No concurrent treatment for another active malignancy

• No concurrent warfarin for anticoagulation

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent investigational or commercial anticancer agents or therapies