Selumetinib and Erlotinib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

This phase II trial studies how well giving selumetinib and erlotinib hydrochloride together works in treating patients with locally advanced or metastatic pancreatic cancer that is refractory to chemotherapy. Selumetinib and erlotinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description public domain (ClinicalTrials.gov)

PRIMARY OBJECTIVES: l. To assess overall survival (as measured by median survival and proportion of patients alive at 24 weeks) in patients with advanced pancreatic cancer who have received one prior line of systemic therapy when treated with the combination of AZD6244 (selumetinib) and erlotinib (erlotinib hydrochloride). SECONDARY OBJECTIVES: I. Progression-free survival (median progression-free survival \[PFS\] and proportion of patients with PFS at 12 and 24 weeks). II. Cancer antigen (CA)19-9 biomarker response (defined as a 50% decline in serum CA19-9 level from baseline in patients with \> 2 x upper limit of normal \[ULN\] CA19-9 measurement). III. Objective radiographic response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. IV. Safety and toxicity profile of the combination of AZ6244 and erlotinib. OUTLINE: Patients receive selumetinib orally (PO) once daily (QD) and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2-3 months.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) [Up to 2 years]. Median, months (95% Confidence Interval). Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 7.3 (5.2 to 8.0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression-free Survival (PFS) [From first dose of study treatment to the date of objective progression, or death due to cancer or unknown cause, or to the date of withdrawal from the trial from unknown reasons, assessed up to 2 years]. Median, months (95% Confidence Interval). Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 1.9 (1.4 to 3.3).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

CA19-9 Biomarker Response (Defined as a 50% Decline in Serum CA19-9 Level From Baseline in Patients With > 2 x ULN CA19-9 Measurement) [Up to 2 years]. Number, percentage of participants. Treatment (Erlotinib Hydrochloride, Selumetinib) (n=34): 38.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Objective Radiographic Response by RECIST Criteria [Up to 2 years]. Number, participants. Complete Response (CR): Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 0. Complete+Partial Response: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [Up to 30 days after completion of study treatment]. Number, events. Rash: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 10. Diarrhea: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 6. Nausea/vomiting: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 4. Fatigue: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 3. AST/ALT elevation: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 4. Anorexia: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 0. Anemia: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 5. Dysgeusia: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 0. Eye disorders: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 0. Pruritus: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 0. Hypertension: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 6. Thrombocytopenia: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 1. Leukopenia/neutropenia: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 1. Thromboembolic event (incl. cerebral): Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 3. Elevated creatinine: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 0.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Survival at 24 Weeks [24 weeks]. Number, percentage of participants. Treatment (Erlotinib Hydrochloride, Selumetinib) (n=46): 58.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Patients With Dose Modifications and Reason for Dose Modification. [Up to final day of study treatment]. Number, participants. RASH: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=18): 8. Diarrhea: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=18): 7. NAUSEA/VOMITING: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=18): 5. Fatigue: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=18): 3. Hypertension: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=18): 1. TRANSAMINITIS: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=18): 1. UNKNOWN: Treatment (Erlotinib Hydrochloride, Selumetinib) (n=18): 1.