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CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
This study has been completed.

First Received on January 9, 2004.   Last Updated on July 21, 2010   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075647
  Purpose

RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well CCI-779 works in treating patients with locally advanced or metastatic pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: temsirolimus
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study 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):

Study Start Date: December 2003
Detailed Description:

OBJECTIVES:

Primary

  • Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779.

Secondary

  • Determine time to progression, progression-free survival, overall survival, and tumor response rate in patients with measurable disease treated with this drug.
  • Correlate biomarkers of response with clinical response in patients treated with this drug.
  • 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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas

    • Locally advanced or metastatic disease
  • Radiographic evidence of disease
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)

Renal

  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance ≥ 50 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent prophylactic hematopoietic colony-stimulating factors

Chemotherapy

  • 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

Endocrine therapy

  • Not specified

Radiotherapy

  • See Chemotherapy

Surgery

  • See Chemotherapy

Other

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

Locations
United States, Texas
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Henry Q. Xiong, MD, PhD M.D. Anderson Cancer Center
Investigator: James L. Abbruzzese, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00075647     History of Changes
Other Study ID Numbers: CDR0000347405, MDA-2003-0530, NCI-6182
Study First Received: January 9, 2004
Last Updated: July 21, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

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

ClinicalTrials.gov processed this record on February 12, 2012