CCI-779 In Treating Patients With Locally Advanced Or Metastatic Pancreatic Cancer

Study Overview

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

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

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.

Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer

DRUG: temsirolimus
OTHER: laboratory biomarker analysis

NCI-2012-02567
MDA-2003-0530
N01CM17003 (U.S. NIH Grant/Contract)
CDR0000347405 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2004-01-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-01-16
First Submitted that Met QC Criteria 2004-01-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-01-17
First Posted (ESTIMATED) 2004-01-12	Results First Posted N/A	Last Verified 2013-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment (temsirolimus) Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.	DRUG: temsirolimus Given IV OTHER: laboratory biomarker analysis Correlative studies

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment (temsirolimus)

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

DRUG: temsirolimus

Given IV

OTHER: laboratory biomarker analysis

Correlative studies

Primary Outcome Measures	Measure Description	Time Frame
Overall survival (OS)	The method of Thall and Simon will be employed.	6 months

Secondary Outcome Measures	Measure Description	Time Frame
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	Up to 2 years
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
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.	Up to 2 years
Levels of PTEN, AKT, and PI3K	Expression levels will be correlated with patient survival duration using Cox proportional hazard regression analysis	Up to 2 years
Expression and phosphorylation status of p70s6k	Descriptive statistics will be applied to report the mean, duration of the effects on p70s6k phosphorylation.	Up to 7 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Henry Xiong, M.D. Anderson Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record