CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

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

Summary

Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with locally advanced or metastatic pancreatic cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• Locally advanced or metastatic disease

• Radiographic evidence of disease

• No known brain metastases

• Performance status - ECOG 0-2

• More than 3 months

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)

• Creatinine ≤ 1.5 mg/dL

• Creatinine clearance ≥ 50 mL/min

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Fasting serum cholesterol ≤ 350 mg/dL

• Fasting triglycerides ≤ 400 mg/dL

• No ongoing or active infection

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

• No other concurrent uncontrolled illness

• No concurrent prophylactic hematopoietic colony-stimulating factors

• No prior chemotherapy for metastatic pancreatic cancer

• More than 2 months since prior adjuvant or neoadjuvant chemoradiotherapy for resected pancreatic cancer

• Must have radiographic evidence of recurrent disease

• More than 2 months since prior chemoradiotherapy for locally advanced pancreatic cancer

• Must have radiographic evidence of disease progression

• See Chemotherapy

• See Chemotherapy

• No other concurrent investigational or commercial agents or therapies for the malignancy

• No other concurrent anticancer therapy

• No concurrent combination antiretroviral therapy for HIV-positive patients