search
Back to results

RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RAD001
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring RAD001, metastatic pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RAD001

Arm Description

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.

Outcomes

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.
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
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.
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.
Overall survival was defined as the time from study entry until death from any cause.

Full Information

First Posted
December 6, 2006
Last Updated
July 23, 2014
Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Novartis
search

1. Study Identification

Unique Protocol Identification Number
NCT00409292
Brief Title
RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer
Official Title
Phase II Study of RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Novartis

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
RAD001, metastatic pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAD001
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
RAD001
Intervention Description
Taken orally daily for as long as the participant continues to receive a benefit.
Primary Outcome Measure Information:
Title
To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.
Description
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.
Time Frame
two months
Secondary Outcome Measure Information:
Title
To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer
Description
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.
Time Frame
Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001.
Title
to Assess Response Rate Associated With RAD001 in This Patient Population.
Description
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.
Time Frame
2 years
Title
to Assess Overall Survival Associated With RAD001 in This Patient Population.
Description
Overall survival was defined as the time from study entry until death from any cause.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Fuchs, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19047305
Citation
Wolpin BM, Hezel AF, Abrams T, Blaszkowsky LS, Meyerhardt JA, Chan JA, Enzinger PC, Allen B, Clark JW, Ryan DP, Fuchs CS. Oral mTOR inhibitor everolimus in patients with gemcitabine-refractory metastatic pancreatic cancer. J Clin Oncol. 2009 Jan 10;27(2):193-8. doi: 10.1200/JCO.2008.18.9514. Epub 2008 Dec 1.
Results Reference
result

Learn more about this trial

RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer

We'll reach out to this number within 24 hrs