Clinical trialPhase 2Completed
Sorafenib and Erlotinib in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery
A Phase II Trial of Sorafenib and Erlotinib in Unresectable Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- October 2008
- Expected end
- November 2012
- Enrollment
- 37 participants
- Sites
- 6
- Primary outcomes
- Number of Patients With Progression-free Survival
- Sponsor
- Other
- Results posted
- 2012-09-28
- Last update
- 25 June 2014
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Brief summary public domain (ClinicalTrials.gov)
RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib works in treating patients with pancreatic cancer that cannot be removed by surgery.
Detailed description public domain (ClinicalTrials.gov)
OBJECTIVES: Primary * To determine the efficacy of sorafenib tosylate in combination with erlotinib hydrochloride in patients with unresectable pancreatic cancer. Secondary * To determine the response rate in patients treated with this regimen. * To determine the progression-free survival of patients treated with this regimen at 4 months. * To evaluate the safety profile of this regimen in these patients. * To evaluate the change in serum Ca 19-9 levels at baseline and at 8-week intervals. * To evaluate the plasma proteomic profile at baseline and at 8 weeks to correlate with clinical parameters in order to identify potential prognostic or predictive markers. * To analyze single-nucleotide polymorphisms on DNA obtained from pretreatment blood samples to evaluate toxicity and response to erlotinib hydrochloride. OUTLINE: Patients receive oral sorafenib tosylate once or twice daily and oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Serum samples are collected at baseline and at 8-week intervals to measure Ca 19-9 levels, and plasma and buffy coat samples are collected at baseline and at week 8 for proteomic assessment and genotyping of single-nucleotide polymorphisms associated with response and toxicity to erlotinib hydrochloride. After completion of study treatment, patients are followed up every 3 months.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Patients With Progression-free Survival [at 8 weeks]. Number, participants. Treatment (n=23): 10.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Rate [at 4 months]. Number, participants. Complete Response: Treatment (n=27): 0. Partial Response: Treatment (n=27): 0. Stable Disease: Treatment (n=27): 8. Progressive Disease: Treatment (n=27): 19.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Patients With Progression-free Survival [at 4 months]. Number, participants. Treatment (n=20): 4.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Patients With Worst Grade Toxicities [every 4 weeks and every 8 weeks in follow-up to resolution of toxicity]. Number, participants. number of patients with worst grade toxicity - 1: Treatment (n=36): 1. number of patients with worst grade toxicity - 2: Treatment (n=36): 5. number of patients with worst grade toxicity - 3: Treatment (n=36): 26. number of patients with worst grade toxicity - 4: Treatment (n=36): 3. number of patients with worst grade toxicity - 5: Treatment (n=36): 1.