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Efficacy and feasibility of the combination of everolimus and capecitabine in patients with metastatic or locally advanced pancreatic carcinoma

Efficacy and feasibility of the combination of everolimus and capecitabine in patients with metastatic or locally advanced pancreatic carcinoma - everolimus and capecitabine in pancreatic cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31280
Enrollment
33
Registered
2007-04-18
Start date
2007-03-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancraetic carcinoma pancreatic cancer

Interventions

Everolimus will be administrated daily at a dose of 9 mg, devided into 2 doses. Capecitabine is an orally administered fluoropirimidine. The dose will be 1000 mg/m2 twice daily for 2 weeks, with one

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Signed informed content obtained prior to treatment - Cytological or histological confirmed adenocarcinoma of the pancreas - Metastatic or non-resectable disease - Measurable lesion according to RECIST criteria - ECOG/ WHO performance 0-2 - Age > 18 years - Life expectancy > 3 months - Adequate renal function (creatinine 3.0 x 10 9/L, platelets > 100 x 10 9/L) - Mentally, physically, and geographically able to undergo treatment and follow up

Exclusion criteria

Exclusion criteria: - Clinical or radiological evidence of CNS metastases - Pregnancy (positive serum pregnancy test) and lactation - Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study will be six-month survival rate.

Secondary

MeasureTime frame
As secondary endpoints are defined: - Objective complete and partial response rate - Time to treatment failure - Overall survival - One year survival rate - Toxicity profile

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)