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

Pancreatic Cancer Clinical Trial

Official title:

Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376948
• Other study ID #: CDR0000495776
• Secondary ID: P30CA022453WSU-2
• Status: Completed
• Phase: Phase 2
• Start date: May 2005
• Est. completion date: March 2010

Study information

• Verified date: February 2021
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• 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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Dietary Supplement:
• genistein

Drug:
• erlotinib hydrochloride

• gemcitabine hydrochloride

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Alive		at 6 months
Primary	Median Overall Survival Estimate		up to 17 months
Secondary	Overall Objective Response Rate (Complete and Partial Response)	Imaging tests (CT scan, CXR [Chest X-Ray], MRI or imaging studies as clinically indicated	Every 8 weeks
Secondary	Response Duration	Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions. Partial response is defined as greater than or equal to 30% reduction in the sum of the longest diameteres of target lesions, taking as reference the baseline sum of the longest diameters.	Every 8 weeks
Secondary	Time to Treatment Failure	Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions.	Every 8 weeks
Secondary	Time to Progression	Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions.	Every 8 weeks
Secondary	Grade 3 or Higher Toxicity Evaluation	Toxicity evaluation using NCI-CTC (Common Terminology Criteria) v.3 criteria; CBC (complete blood count) with differential white cell and platelet counts; Serum sodium, potassium, chloride, bicarbonate, AST, ALT, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, and albumin; Serum CA 19-9	First day of each cycle
Secondary	pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation	Tumor tissue collected from paraffin	At start of study