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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075647
First received: January 9, 2004
Last updated: January 16, 2013
Last verified: January 2013

January 9, 2004
January 16, 2013
December 2003
March 2005   (final data collection date for primary outcome measure)
Overall survival (OS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The method of Thall and Simon will be employed.
Not Provided
Complete list of historical versions of study NCT00075647 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    95% confidence interval will be presented
  • Duration of response [ Time Frame: From the time of objective response to the time of progressive disease, assessed up to 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    Descriptive statistics (mean, standard deviation, median, and range) will be displayed for relevant laboratory parameters.
  • Levels of PTEN, AKT, and PI3K [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Expression levels will be correlated with patient survival duration using Cox proportional hazard regression analysis
  • Expression and phosphorylation status of p70s6k [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    Descriptive statistics will be applied to report the mean, duration of the effects on p70s6k phosphorylation.
Not Provided
Not Provided
Not Provided
 
CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage II Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Drug: temsirolimus
    Given IV
    Other Names:
    • CCI-779
    • cell cycle inhibitor 779
    • Torisel
  • Other: laboratory biomarker analysis
    Correlative studies
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.
Interventions:
  • Drug: temsirolimus
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Not Provided
March 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00075647
NCI-2012-02567, MDA-2003-0530, N01CM17003, CDR0000347405
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Henry Xiong M.D. Anderson Cancer Center
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP