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 (Responsible Party):
Brian Wolpin, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00409292
First received: December 6, 2006
Last updated: July 23, 2014
Last verified: July 2014
  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: two months ] [ Designated as safety issue: No ]

    The Outcome Measure is reporting the number of participants experiencing Progression-free Survival at 2 months after treatment.

    The study was designed with a primary end point of progression-free survival (PFS), defined as the time from study entry to documentation of progressive disease or death from any cause. On the basis of prior studies of second-line treatment in metastatic pancreatic cancer, we estimated that such treatment has been associated with a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this patient population.



Secondary Outcome Measures:
  • To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer [ Time Frame: Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001. ] [ Designated as safety issue: Yes ]
    Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001. The number of patients with treatment-related adverse events are reported.

  • to Assess Response Rate Associated With RAD001 in This Patient Population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The secondary objectives of the study were to assess tumor response rate and overall survival. Patients were required to have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST, for target lesions assessed by CT: Complete Response (CR) is Disappearance of all target lesions; Partial Response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) equals CR + PR.

  • to Assess Overall Survival Associated With RAD001 in This Patient Population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from study entry until death from any cause.


Enrollment: 33
Study Start Date: January 2007
Study Completion Date: May 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001

RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.

Four weeks of study drug was considered to be one cycle of treatment.

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
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: 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: Brian Wolpin, MD, MPH, Overall PI, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00409292     History of Changes
Other Study ID Numbers: 06-197
Study First Received: December 6, 2006
Results First Received: April 30, 2014
Last Updated: July 23, 2014
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
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014