Status:
WITHDRAWN
Study of Everolimus in the Treatment of Advanced Malignancies in Patients With Peutz-Jeghers Syndrome
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Peutz-Jeghers Syndrome
Neoplastic Processes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this pilot study the investigators will treat all patients known with Peutz-Jeghers syndrome (PJS) who are diagnosed with advanced malignancies with everolimus 10mg daily until disease progression....
Eligibility Criteria
Inclusion
- Tow cohorts of PJS patients will be included. Cohort 1: Advanced malignancy Cohort 2: High risk polyps
- General inclusion criteria:
- Known Peutz-Jeghers disease (with LKB1 mutation)
- No concurrent systemic anti cancer treatment
- No prior treatment with m-TOR inhibitor
- Prior malignancies or concurrent second malignancies are allowed
- Prior systemic therapy is permitted with a washout time of at least 4 weeks
- ECOG/ WHO performance 0-2
- Age \> 18 years
- Adequate renal function (defined as creatinine \< 150 μmol/L)
- Adequate liver function (bilirubin \< 1.5 times upper limit of normal, ALAT or ASAT \< 5.0 times upper limit of normal in case of liver metastases and \< 2.5 the upper limit of normal in absence of liver metastases
- Adequate bone marrow function (WBC \> 3.0 x 10 9/L, platelets \> 100 x 10 9/L)
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- No pregnancy or lactating and ifof childbearing potential patients must agree to use a reliable contraceptive method throughout the study
- No serious concomitant systemic disorder that would compromise the safety of the patient,at the discretion of the investigator
- Signed informed consent according to ICH/GCP.
- No uncontrolled symptomatic hyperglycaemia
- Specific inclusion criteria for cohort 1:
- Cytological or histological confirmed carcinoma
- Metastatic or non-resectable disease
- Patients with clinically and/or radiographically documented measurable lesion according to
- RECIST criteria:
- X-ray, physical exam \> 20 mm
- Spiral CT scan \> 10 mm
- Non-spiral CT scan \> 20 mm
- Specific inclusion criteria for cohort 2:
- Known high risk polyps (definition see page 19)
- Ability to undergo endoscopies
- Specific Exclusion criteria:
- Symptomatic PJ-polyps, defined as polyps likely to be responsible/causal for the abdominal symptoms the patient presents with.
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01178151
Start Date
October 1 2010
End Date
April 1 2015
Last Update
April 22 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Academic Medical Center
Amsterdam, Netherlands, 1105AZ
2
Erasmus Medical Center
Rotterdam, Netherlands, 3000 CA