Gemcitabine and Pulse Dose Erlotinib in Second Line Treatment of Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2020-09-03
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see whether an altered schedule of giving erlotinib in combination with gemcitabine will be safe and might improve the results of the treatment for advanced cancer of the pancreas.

Gemcitabine and erlotinib are commercially available. Gemcitabine is FDA approved as first-line treatment for patients with locally advanced, unresectable or metastatic cancer of the pancreas. Erlotinib is FDA approved in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

The FDA recommended dose for erlotinib is 100 mg daily. This study will investigate the experimental administration of higher doses of erlotinib given for only three days twice a month, a schedule called "pulse dosing".

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tony Reid, M.D., Ph.D.
• Collaborator: Genentech, Inc.
• Treatments: Erlotinib Hydrochloride; Gemcitabine

Criteria

Inclusion Criteria:

• Pathologically confirmed advanced pancreatic cancer defined as non-operable in a curative intent, locally recurrent, or metastatic disease.

• Measureable disease by (Response Evaluation Criteria in Solid Tumors) RECIST v1.1. Measureable lesions will be confirmed by radiological imaging.

• Progressive disease by (Response Evaluation Criteria in Solid Tumors) RECIST criteria during or after treatment with first-line chemotherapy (disease free interval must be less than 6 months) and have not received further second-line chemotherapy. Patients treated with prior chemo-radiation to the primary pancreatic tumor, for which the chemotherapeutic agent was used as a radio-sensitizing agent, are eligible.

• Age >18 years.

• Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0-2.

• Life expectancy of >2 months.

• Adequate laboratory parameters: All tests to be performed within 5 days prior to the first dose of erlotinib

• Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.

• Women of child bearing potential must have a negative pregnancy test at screening.

Exclusion Criteria:

• Radiation within 4 weeks of study enrollment. Radiotherapy not permitted while on study. Exception: palliative radiotherapy of metastasis in extremities is allowed, but such lesions cannot be used as target or non-target lesions.

• Investigational compound within 4 weeks of enrollment or who are planning to receive other investigational drugs while participating in the study.

• Chemotherapy, biologics, immunotherapy, vaccine, cytokine therapy within 4 weeks prior to enrollment.

• Presence of untreated and/or symptomatic central nervous system (CNS) metastasis.

• Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, chronic renal disease, chronic pulmonary disease or active uncontrolled infection).

• Known diagnosis of human immunodeficiency virus (HIV) infection.

• Presence of any other active or suspected acute or chronic uncontrolled infection or known symptomatic active hepatitis B or C.

• Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease.

• History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer, cervical cancer in situ, localized biopsy-proven prostate cancer, or stage I colon cancer.

• Surgery within 3 weeks prior to enrollment.

• Patients taking Coumadin® or other agents containing warfarin, rivaroxaban, or dabigatran (exception: low dose Coumadin® (1 mg or less daily) administered prophylactically for maintenance of in-dwelling lines or ports is allowed).

• Patients taking any medications or substances that are inhibitors or inducers of Cytochrome P450, family 3, subfamily A (CYP3A).

• Female patients who are pregnant or breast-feeding.