Clinical trial NCT00409292: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: RAD001
metastatic pancreatic cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
name: Novartis
First posted: 2006-12-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.
timeFrame: two months
Secondary outcomes:
measure: To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer
timeFrame: Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001.
measure: to Assess Response Rate Associated With RAD001 in This Patient Population.
timeFrame: 2 years
measure: to Assess Overall Survival Associated With RAD001 in This Patient Population.
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Charles Fuchs, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.