Maintenance therapy with Sunitinib in pancreatic adenocarcinoma metastatic: Phase II randomized trial.

• Conditions: Pancreatic adenocarcinoma metastatic; MedDRA version: 14.1Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-000814-65-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE DI MILANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-10
• Last Update Posted: 18 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Cytological or histological diagnosis of pancreatic adenocarcinoma
2. Presence of metastatic disease
3. No previous chemiotherapy, except induction therapy, for pancreatic neoplasia.
4. Demonstrated progression absence at 6 months since the beginning of chemiotherapic treatment, indipendently from the used scheme and from the response entity (stable disease, partial response, complete response):
a. normal value or not increasing more than 20 % respect to previous evaluation of tumor marker (CA19.9 or CEA). The previous evaluation should be performed at least 30 days before.
b. Two consecutive CT scan or MRI evaluations within at least 6 weeks, that document pregression absence according to RECIST criteria (NO increase > 20% of the sum of the longest diameter of all target lesions; NO new lesions; NO evident progression of any pre-existing non-target lesion)
5. Interval not shorter that 3 weeks and not longer than 8 weeks since the last chemiotherapy administration (an interval not shorter than one week since the end of capecitabine or 5FU administration in continuous infusion is sufficient)
6. No duodenal or gastric or intestinal infiltration documented by CT scan or RMI.
7. CT scan or RMI performed within 3 weeks before enrollment
8. NO previous therapy with other antiangiogenic drugs (for instance: bevacizumab, sorafenib, pazopanib,AZD2171, vatalanib, VEGF trap,sunitinib)
9. Age > 18 years
10. Karnofsky performance status > 50%
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of hypertension except if well controlled or with antihypertensive therapy.
Major surgery in the month before study entry and complete recovery of surgical intervention.
Concomitant intake or at least 7 days interval from CYP3A4 inhibitors stop (antifungal azolic such as ketoconazole, itraconazole, diltiazem, claritromicine, eritromicine, verapamil, delavirdine, HIV protease inhibitors such as indinavir, saquinavir, ritonavir, atazanavir, nelfinavir).
Concomitant intake or at least 12 days interval from CYP3A4 inducer stop(rifampine, rifabutine, carbamazepina, fenobarbital, fenitoine, hypericum perforatum, efavirenz, tipranavir).
Concomitant intake of drugs with antiarrhythmic potential (terfenadine, quinidine, procainamide, disopiramide, solatole, probucole, bepridil, aloperidol, risperidone, indapamide, flecainide)
Concomitant intake of therapeutic doses of anticoagulant drugs derived from warfarin (warfarin at < 2 mg/die doses or low molecular weight heparins for patients with INR < 1.5 for prophilaxis of thrombosis are allowed)
Previous or concomitant neoplasia, except carcinoma in situ of uterine cervix and skin epidermoidal carcinoma appropriately treated or other neoplasms if the patient has been disease free for at least 5 years.
Concomitant treatment with other investigational drugs, or hormones or radiotherapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate progression free survival at 6 months (PFS-6) from the beginning of the trial in patients affected by pancreatic metastatic adenocarcinoma free of progression after 6 months first line chemiotherapy and underwent maintenance therapy.;Secondary Objective: To evaluate overall survival, response rate, response time, toxicities to treatment, and the impact on quality of life in patients enrolled in the trial.;Primary end point(s): The primary endpoint is the rate of patients free from progression at 6 months since the enrollment date (PFS-6).