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

Primary Purpose

Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temsirolimus
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (temsirolimus)

Arm Description

Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Overall survival (OS)
The method of Thall and Simon will be employed.

Secondary Outcome Measures

Overall response rate defined as the number of patients who achieved CR or PR divided by the number of patients treated
95% confidence interval will be presented
Duration of response
Time to progression (TTP)
Systemic and local adverse events assessed using the established National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Descriptive statistics (mean, standard deviation, median, and range) will be displayed for relevant laboratory parameters.
Levels of PTEN, AKT, and PI3K
Expression levels will be correlated with patient survival duration using Cox proportional hazard regression analysis
Expression and phosphorylation status of p70s6k
Descriptive statistics will be applied to report the mean, duration of the effects on p70s6k phosphorylation.

Full Information

First Posted
January 9, 2004
Last Updated
January 16, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00075647
Brief Title
CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Official Title
Phase II Trial of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (temsirolimus)
Arm Type
Experimental
Arm Description
Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
temsirolimus
Other Intervention Name(s)
CCI-779, cell cycle inhibitor 779, Torisel
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
The method of Thall and Simon will be employed.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall response rate defined as the number of patients who achieved CR or PR divided by the number of patients treated
Description
95% confidence interval will be presented
Time Frame
Up to 2 years
Title
Duration of response
Time Frame
From the time of objective response to the time of progressive disease, assessed up to 2 years
Title
Time to progression (TTP)
Time Frame
From the time of the study entry to the time of relapse or progression, assessed up to 2 years
Title
Systemic and local adverse events assessed using the established National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Description
Descriptive statistics (mean, standard deviation, median, and range) will be displayed for relevant laboratory parameters.
Time Frame
Up to 2 years
Title
Levels of PTEN, AKT, and PI3K
Description
Expression levels will be correlated with patient survival duration using Cox proportional hazard regression analysis
Time Frame
Up to 2 years
Title
Expression and phosphorylation status of p70s6k
Description
Descriptive statistics will be applied to report the mean, duration of the effects on p70s6k phosphorylation.
Time Frame
Up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Xiong
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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