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Home > "C" Clinical Trials Conditions > CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer  CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
For Condition: recurrent pancreatic cancer,stage 2 pancreatic cancer,stage 3 pancreatic cancer,stage 4A pancreatic cancer,adenocarcinoma of the pancreas,stage 4B pancreatic cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have locally advanced or metastaticpancreatic cancer.
Details: OBJECTIVES: Primary - Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779. Secondary - Determine time to progression, progression-free survival, overall survival, and tumor response rate in patients with measurable disease treated with this drug. - Correlate biomarkers of response with clinical response in patients treated with this drug. - Determine the safety and toxicity of this drug in these patients. OUTLINE: This is an open-label study. Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the pancreas - Locally advanced or metastatic disease - Radiographic evidence of disease - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 3 months Hematopoietic - WBC 3,000/mm^3 - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - Bilirubin 1.5 times upper limit of normal (ULN) - AST and ALT 2.5 times ULN (5 times ULN if liver metastases are present) Renal - Creatinine 1.5 mg/dL OR - Creatinine clearance 50 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - 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 PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent prophylactic hematopoietic colony-stimulating factors Chemotherapy - 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 Endocrine therapy - Not specified Radiotherapy - See Chemotherapy Surgery - See Chemotherapy Other - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesAbbruzzese, , M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Henry Xiong 713-792-2828
Additional Information:
Study ID Numbers: CDR0000347405; MDA-2003-0530,NCI-6182
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075647
Other Stage 2 Pancreatic Cancer Studies:
1. Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
2. Perifosine in Treating Patients With Advanced Pancreatic Cancer
3. Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer
4. DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer
5. 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
Related Studies:
Other stage 2 pancreatic cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
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