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

NCT00376948 | Completed Phase 2 Results DMC

• 4 other identifiers: CDR0000495776P30CA022453WSU-2005-006WSU-025806MP4F
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage III pancreatic cancer; stage IV pancreatic cancer; recurrent pancreatic cancer

Outcome Measures

Primary Outcomes (2)

• Patients Alive

  at 6 months

• Median Overall Survival Estimate

  up to 17 months

Secondary Outcomes (6)

• Overall Objective Response Rate (Complete and Partial Response)

  Every 8 weeks

• Response Duration

  Every 8 weeks

• Time to Treatment Failure

  Every 8 weeks

• Time to Progression

  Every 8 weeks

• Grade 3 or Higher Toxicity Evaluation

  First day of each cycle

Study Arms (1)

Novasoy®, Gemcitabine & Erlotinib

EXPERIMENTAL

Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, \& 15; Erlotinib 150 mg day 1 until day 28

Dietary Supplement: genistein; Drug: erlotinib hydrochloride; Drug: gemcitabine hydrochloride

Interventions

genistein DIETARY_SUPPLEMENT

Novasoy®, Gemcitabine & Erlotinib

erlotinib hydrochloride DRUG

Novasoy®, Gemcitabine & Erlotinib

gemcitabine hydrochloride DRUG

Novasoy®, Gemcitabine & Erlotinib

Eligibility Criteria

• Age: 21 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Genistein; Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinazolines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Limitations and Caveats

This study was stopped early due to the lack of efficacy.

Results Point of Contact

• Title: Almhanna Khaldoun, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

almhanna@karmanos.org

313-576-8746

Study Officials

• Khaldoun Almhanna, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

• Fazlul H. Sarkar, PhD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 15, 2006
• Study Start: May 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 1, 2021
• Results First Posted: August 26, 2014

Record last verified: 2021-02

Locations

US (2)