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

January 16, 2013 updated by: National Cancer Institute (NCI)

Phase II Trial of CCI-779 in 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Other: laboratory biomarker analysis
Correlative studies
Drug: temsirolimus
Given IV
Other Names:
  • Torisel
  • CCI-779
  • cell cycle inhibitor 779

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: Up to 2 years
95% confidence interval will be presented
Up to 2 years
Duration of response
Time Frame: From the time of objective response to the time of progressive disease, assessed up to 2 years
From the time of objective response to the time of progressive disease, assessed up to 2 years
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
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)
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
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
Time Frame: Up to 7 days
Descriptive statistics will be applied to report the mean, duration of the effects on p70s6k phosphorylation.
Up to 7 days

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Henry Xiong, M.D. Anderson Cancer Center

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 Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

January 9, 2004

First Submitted That Met QC Criteria

January 11, 2004

First Posted (Estimate)

January 12, 2004

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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