Clinical trialPhase 2Completed
Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
A Phase II Trial to Assess the Efficacy of Efavirenz as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- August 2008
- Expected end
- July 2010
- Enrollment
- 19 participants
- Sites
- 1
- Primary outcomes
- Percentage of Patients in Non-progression at 2 Months
- Sponsor
- Other
- Results posted
- 2025-08-28
- Last update
- 28 August 2025
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Brief summary public domain (ClinicalTrials.gov)
RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well efavirenz works as second-line therapy in treating patients with metastatic pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
OBJECTIVES: Primary * Evaluate the efficacy of efavirenz as second-line monotherapy, in terms of non-morphological progression at 2 months, in patients with metastatic adenocarcinoma of the pancreas. Secondary * Evaluate non-morphological progression in these patients at 4 months. * Evaluate non-biological progression in these patients at 2 and 4 months. * Evaluate the quality of life of these patients at 2 and 4 months. * Evaluate the overall, progression-free, and event-free survival of these patients. * Evaluate the tolerability and safety profile of efavirenz in these patients. OUTLINE: This is a multicenter study. Patients receive oral efavirenz once daily in the absence of disease progression or unacceptable toxicity. Patients complete quality-of-life questionnaires using the QLQ-C30 at baseline and at 2 and 4 months. After completion of study therapy patients are followed up every 2 months.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Percentage of Patients in Non-progression at 2 Months [2 months]. Number, percentage of participants (95% Confidence Interval). Efavirenz (n=14): 14.3 (1.8 to 42.8).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Percentage of Patients in Non-progression at 4 Months [4 months]. Number, percentage of participants (95% Confidence Interval). Efavirenz (n=11): 9.1 (0.2 to 41.3).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Percentage of Patients in Non-biological Progression at 2 Months [2 months]. Number, percentage of participants (95% Confidence Interval). Efavirenz (n=14): 31.4 (4.7 to 50.8).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [Through Database Cutoff Date of 06-July-2011 ( median follow-up time of 397 days)]. Median, days (95% Confidence Interval). Efavirenz (n=19): 216 (59 to 390).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Event-free Survival [Through Database Cutoff Date of 06-July-2011 ( median follow-up time of 397 days)]. Median, days (95% Confidence Interval). Efavirenz (n=19): 52 (22 to 56).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival [Through Database Cutoff Date of 06-July-2011 ( median follow-up time of 397 days)]. Median, days (95% Confidence Interval). Efavirenz (n=19): 54 (23 to 56).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Quality of Life Score [2 months]. Median, score on a scale (Full Range). Physical functionning score: Efavirenz (n=19): 73.3 (53.3 to 100). Role functionning score: Efavirenz (n=19): 75 (50 to 100). Emotional Functioning score: Efavirenz (n=19): 83.3 (66.7 to 83.3). Cognitive Functioning score: Efavirenz (n=19): 75 (66.7 to 100). Social Functioning score: Efavirenz (n=19): 75 (50 to 100). Global health status score: Efavirenz (n=19): 58.3 (50 to 83.3). Fatigue score: Efavirenz (n=19): 44.4 (22.2 to 100). Nausea / Vomiting score: Efavirenz (n=19): 0 (0 to 16.7). Pain score: Efavirenz (n=19): 41.7 (0 to 66.7). Dyspnoea score: Efavirenz (n=19): 33.3 (0 to 33.3). Insomnia score: Efavirenz (n=19): 33.3 (0 to 66.7). Appetite loss score: Efavirenz (n=19): 16.7 (0 to 66.7). Constipation score: Efavirenz (n=19): 0 (0 to 66.7). Diarhoea score: Efavirenz (n=19): 16.7 (0 to 66.7). Financial Problems score: Efavirenz (n=19): 0 (0 to 33.3).