A phase II trial to assess the efficacy of efavirenz as second-line monotherapy for the treatment of advanced pancreatic adenocarcinomas. - PANTER

• Conditions: Advanced pancreatic adenocarcinomas who escaped to a first ligne chemotherapy treatment based on Gemcitabine.; MedDRA version: 9.1Level: LLTClassification code 10033613Term: Pancreatic carcinoma recurrent

• Registration Number: EUCTR2008-004273-18-FR
• Lead Sponsor: Institut Bergonié

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Provision of written informed consent prior any study-related procedures.
2. Male/Female aged 18 years and over.
3. Previously confirmed histological diagnosis of pancreas adenocarcinoma.
4. Evidence of metastases radiologically documented, in non-irradiated zone. Disease measured according to RECIST criteria.
5. Escape to a first line chemotherapy treatment based on Gemcitabine.
6. Adjuvant chemotherapy (one line only) and/or radiotherapy authorized.
7. Word Health Organisation (WHO) performance status ranged from 0 to 2 or Karnofsky > 60%.
8. Haematological function: polynuclear neutrophiles (PNN) >= 1,5 G/L, platelets (PL) >= 100 G/L, haemoglobin >= 10 g/dL.
9. Renal function: plasmatic creatinine <= 1,25 x LSN.
10. Hepatic function: alkaline phosphatises < 5N, bilirubine < 3N.
11. Negative pregnancy test (betaHCG) and contraception for women in age to procreate.
12. Clinical and biological examination within the 7 days before inclusion and start treatment.
13. Radiological TDM and/or IRM test within the 30 days before inclusion.
14. Compliance of the subjects with treatment rules and study follow-up.
15. Patients with French Social Security in compliance with the French law relating to biomedical research (Huriet Law 88-1138 and related decrees).
Are the trial subjects under 18? no
Number of subjects for this age range:
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

1. Histological types of pancreatic cancer other than adenocarcinomas.
2. Disease not measurable or not measured at the inclusion.
3. Presence of metastases in the central nervous system.
4. Previous other cancer, except:
· If previous cancer is older than 5 years and considered in complete
remission,
· In situ cervical cancer,
· Basocellular cutaneous carcimomas.
5. Subjects receiving second line treatment or more.
6. Known hypersensitivity to study treatment and to their excipients.
7. Severe renal failure.
8. Severe hepatic impairment.
9. Yellow fever vaccine.
10. Concomitant treatment with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, rye alkaloids, voriconazole, herbal extract from St. John's wort (Hypericum perforatum).
11. Depressive status (with a score = 19 on the HAD scale).
12. Pregnancy or lactation.
13. Any unresolved toxicity greater than CTC grade 1 from previous anticancer therapy.
14. Currently active diarrhoea that may affect the ability of the patient to absorb the study treatment.
15. Previous exposure or any previous treatment acting on signal transduction pathway.
16. Participation in a clinical study and / or receipt of an investigational drug during the last 30 days.
17. Previous enrolment in the present study.
18. Patient unable to follow and comply with the study procedures because of any geographical, psychiatric, social or psychological reasons.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the efficacy of efavirenz as second-line monotherapy for the treatment of advanced pancreatic adeno-carcinomas in terms of non-morphological progression at 2 months.;Secondary Objective: · Evaluation of non-morphological progression at 4 months,<br>· Evaluation of non biological progression at 2 and 4 months,<br>· Evaluation of the quality of life at 2 and 4 months,<br>· Evaluation of the overall, progression-free, and event-free survivals,<br>· Evaluation of the tolerability and safety profile of efavirenz;Primary end point(s): The primary variable is non-morphological progression as defined by the RECIST criteria (complete response, partial response or stable disease).