Status:
COMPLETED
CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pa...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779. SECONDARY OBJECTIVES: I. Determine time to ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00075647
Start Date
December 1 2003
Last Update
January 17 2013
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030