Clinical trial NCT00560963: Treatment of Patients Suffering From a Progressive Pancreas Carcinoma With Everolimus (RAD001) and Gemcitabine
Official title: Combination of Antiangiogenic Therapy Using the mTOR-inhibitor RAD001 and Low Dose Chemotherapy for Locally Advanced and/or Metastatic Pancreatic Cancer - a Dose Finding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced or Metastatic Pancreatic Adenocarcinoma
Keywords: Advanced or metastatic pancreas carcinoma
gemcitabine
everolimus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-11-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A dose finding study in locally advanced and/or metastatic pancreatic cancer patients


Eligibility criteria: Inclusion criteria:

1. Histologically confirmed locally advanced, irresectable pancreatic adenocarcinoma (head, corpus, tail) with or without distant metastases
2. Adequate bone marrow, liver and renal function on everolimus treatment
3. At least one measurable lesion according to RECIST criteria that has not been previously irradiated.
4. Patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks and recovered since prior minor surgery, completion of radiation, or completion of all prior systemic anticancer.
5. Age \>18 years

Exclusion criteria:

1. Women who are pregnant or breast feeding.
2. Documented intolerance or history of allergy to everolimus or Gemcitabine.
3. History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer
4. Known or symptomatic central nervous system (CNS) metastases or leptomeningeal involvement
5. Chronic treatment with systemic steroids or another immunosuppressive agent
6. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus
7. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin). Quick-value \< 50 % or prothrombine time more than 1,5 fold higher

Other protocol defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of everolimus in combination with Gemcitabine
timeFrame: 8 weeks
Secondary outcomes:
measure: Safety & tolerability, pharmacokinetic assessments of Everolimus and Gemcitabine combination therapy in these patient populations. Phase II objective response rates (ORR), duration of response, progression-free survival (PFS), overall survival (OS)
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Merseburg
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Oberstaufen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: