RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Novartis
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00409292
First received: December 6, 2006
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

The purpose of this research study is to investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory experiments imitating cancer conditions and the results have been promising.


Condition Intervention Phase
Pancreatic Cancer
Drug: RAD001
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To assess progression-free survival of RAD001 at two months in patients with metastatic pancreatic cancer whose disease has progressed on gemcitabine chemotherapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety of RAD001 in patients with metastatic pancreatic cancer [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • to assess response rate and overall survival associated with RAD001 in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: January 2007
Study Completion Date: May 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: RAD001
    Taken orally daily for as long as the participant continues to receive a benefit.
Detailed Description:
  • Participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. Each cycle lasts four weeks during which you will be taking the study drug, RAD001, orally every day.
  • Participants will come into the clinic every other week during the time of enrollment. At each clinic visit blood work will be taken to monitor the participants health and a physical exam will be performed. CT scans will be repeated every 2 months to assess the tumor.
  • Participants will remain on the study as long as they continue to benefit from the study medication.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologic confirmation of pancreatic adenocarcinoma
  • 18 years of age or older
  • At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
  • Treated with gemcitabine-based chemotherapy with documented tumor progression on gemcitabine or intolerance to gemcitabine.
  • Prior treatment with no more than 1 prior chemotherapy regimen for metastatic disease.
  • Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anti-cancer therapy.
  • ECOG performance status 0-1.
  • Life expectancy of greater than 12 weeks.
  • Adequate bone marrow and liver function.
  • Must be able to swallow tablets.

Exclusion Criteria:

  • Prior treatment with an investigational drug within the preceding 4 weeks.
  • Prior treatment with an inhibitor of mTOR
  • Chronic treatment with systemic steroids or another immunosuppressive agent
  • More than one prior chemotherapy treatment for metastatic disease
  • Uncontrolled brain or leptomeningeal metastases, including patient who continue to require glucocorticoids for brain or leptomeningeal metastases.
  • Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
  • Patients with chronic renal insufficiency
  • Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study.
  • Known history of HIV seropositivity
  • Impairment of gastrointestinal function or gastrointestinal disease that my significantly alter the absorption of RAD001.
  • Active, bleeding diathesis or an oral vitamin K antagonist medication
  • Women who are pregnant or breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409292

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Novartis
Investigators
Principal Investigator: Charles Fuchs, MD Dana-Farber Cancer Institute
  More Information

Publications:
Responsible Party: Charles Fuchs, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00409292     History of Changes
Other Study ID Numbers: 06-197
Study First Received: December 6, 2006
Last Updated: June 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
RAD001
metastatic 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 April 23, 2014