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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
  Purpose

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


Condition Intervention Phase
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
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ 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.


Enrollment: 40
Study Start Date: December 2003
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • CCI-779
  • cell cycle inhibitor 779
  • Torisel
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075647

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Henry Xiong M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075647     History of Changes
Other Study ID Numbers: NCI-2012-02567, MDA-2003-0530, N01CM17003, CDR0000347405
Study First Received: January 9, 2004
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014