Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage III Pancreatic Cancer, Stage II Pancreatic Cancer, Stage IV Pancreatic Cancer
Conditions
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 patients with locally advanced or metastatic pancreatic cancer
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 progression, progression-free survival, overall survival, and tumor response rate in patients with measurable disease treated with this drug. II. Correlate biomarkers of response with clinical response in patients treated with this drug. III. 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.
Interventions
DRUGtemsirolimus
Given IV
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 6 months | The method of Thall and Simon will be employed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response | From the time of objective response to the time of progressive disease, assessed up to 2 years | — |
| Time to progression (TTP) | From the time of the study entry to the time of relapse or progression, assessed up to 2 years | — |
| Overall response rate defined as the number of patients who achieved CR or PR divided by the number of patients treated | Up to 2 years | 95% confidence interval will be presented |
| Levels of PTEN, AKT, and PI3K | Up to 2 years | Expression levels will be correlated with patient survival duration using Cox proportional hazard regression analysis |
| Expression and phosphorylation status of p70s6k | Up to 7 days | Descriptive statistics will be applied to report the mean, duration of the effects on p70s6k phosphorylation. |
| Systemic and local adverse events assessed using the established National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) | Up to 2 years | Descriptive statistics (mean, standard deviation, median, and range) will be displayed for relevant laboratory parameters. |
Countries
United States
Outcome results
None listed