Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Study Overview

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genistein may help gemcitabine and erlotinib kill more tumor cells by making tumor cells more sensitive to the drugs. PURPOSE: This phase II trial is studying how well giving genistein together with gemcitabine and erlotinib works in treating patients with locally advanced or metastatic pancreatic cancer.

OBJECTIVES: Primary * Determine the 6-month survival rate of patients with locally advanced or metastatic pancreatic cancer treated with genistein, gemcitabine hydrochloride, and erlotinib hydrochloride. Secondary * Determine the frequency of objective tumor response rate in these patients. * Determine the time to treatment failure in these patients. * Determine the effect of baseline expression of pAKT and activation of NF-kappaB on survival of patients treated with this regimen. * Determine the overall time to disease progression in these patients. * Estimate the quantitative and qualitative toxicities of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral genistein twice daily on days -7 to 28 in course 1 and on days 1-28 in all other courses. Patients also receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Pancreatic Cancer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-09-13	Results First Submitted 2014-08-08	Last Update Submitted that met QC Criteria 2021-02-25
First Submitted that Met QC Criteria 2006-09-13	Results First Submitted that Met QC Criteria 2014-08-08	Last Update Posted (ACTUAL) 2021-03-01
First Posted (ACTUAL) 2006-09-15	Results First Posted 2014-08-26	Last Verified 2021-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Patients Alive		at 6 months
Median Overall Survival Estimate		up to 17 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Histologically or cytologically confirmed pancreatic adenocarcinoma

Locally advanced or metastatic disease by radiological evidence
Must have biopsy material consisting of 10 unstained slides or paraffin-embedded tissue blocks available for correlative studies
No endocrine tumor or lymphoma of the pancreas
No history of CNS (central nervous system) metastases

SWOG (Southwest Oncology Group) performance status 0-1
Life expectancy ≥ 12 weeks
Platelet count ≥ 100,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Bilirubin < 2.0 mg/dL
AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 1.5 times upper limit of normal
Creatinine < 1.5 mg/dL
Albumin > 2.5 g/dL
INR (international normalized ratio) < 1.3 (in the absence of ongoing treatment with warfarin)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active infection
No condition that would limit the ability to receive oral medications
No requirement for a gastrostomy tube for the administration of drugs
No serious concurrent systemic disorder, that, in the opinion of the investigator, is incompatible with the study
No active second primary malignancy within the past year except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin
No allergy to any study drug

No prior chemotherapy or radiotherapy for metastatic disease

Prior adjuvant chemotherapy allowed provided it was completed at least 6 months ago
No prior gemcitabine hydrochloride or epidermal growth factor receptor-inhibiting agents
No other concurrent chemotherapy, immunotherapy, tumor-directed hormonal therapy, or radiotherapy
No other concurrent investigational agents
No other concurrent antitumor therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications