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

NCT02154737 | Completed Phase 1 DMC

• 1 other identifier: 121359
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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".

Conditions

Pancreatic Cancer

Keywords

Pancreatic; Gemcitabine; Gemzar; erlotinib; Tarceva

Outcome Measures

Primary Outcomes (1)

• Rate of dose limiting toxicities of each subject

  Rate will be assessed through summaries of adverse events, clinical laboratory abnormalities, and changes in physical exam and vital signs. All subjects who receive a single dose of study medication will be considered evaluable for safety.

  28 days

Secondary Outcomes (5)

• Overall survival

  2 years

• progression-free survival

  Up to 2 years

• Best tumor response

  up to 2 years

• Changes in the level of serum tumor marker cancer antigen (CA) 19-9

  up to 2 years

• Adverse events related to pulse dose erlotinib and gemcitabine

  From the initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier

Study Arms (1)

erlotinib and gemcitabine

EXPERIMENTAL

Erlotinib will be administered orally on Days 2-4 and Days 16-18 of a 28-day cycle in serial cohorts with doses of 750mg, 1000mg, 1250mg, 1500mg, 1750mg, and 2000mg Gemcitabine will be administered intravenously at 1000 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.

Drug: Gemcitabine; Drug: Erlotinib

Interventions

Gemcitabine DRUG

Gemcitabine will be administered intravenously at 1000 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.

Also known as: Gemzar

erlotinib and gemcitabine

Erlotinib DRUG

Erlotinib will be administered orally on Days 2-4 and Days 16-18 of a 28-day cycle in serial cohorts with doses of 750mg, 1000mg, 1250mg, 1500mg, 1750mg, and 2000mg.

Also known as: Tarceva

erlotinib and gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tony Reid, M.D., Ph.D.: lead
• Genentech, Inc.: collaborator

Study Sites (1)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tony Reid, MD, PhD

  University of California Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 3, 2014
• Study Start: July 1, 2013
• Primary Completion: September 3, 2020
• Study Completion: September 3, 2020
• Last Updated: March 2, 2021

Record last verified: 2021-03

Locations

US (1)