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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00376948
Recruitment Status : Completed
First Posted : September 15, 2006
Results First Posted : August 26, 2014
Last Update Posted : December 4, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Dietary Supplement: genistein Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride Phase 2

Detailed Description:



  • Determine the 6-month survival rate of patients with locally advanced or metastatic pancreatic cancer treated with genistein, gemcitabine hydrochloride, and erlotinib hydrochloride.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer
Study Start Date : May 2005
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: Novasoy®, Gemcitabine & Erlotinib
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

Primary Outcome Measures :
  1. Patients Alive [ Time Frame: at 6 months ]
  2. Median Overall Survival Estimate [ Time Frame: up to 17 months ]

Secondary Outcome Measures :
  1. Overall Objective Response Rate (Complete and Partial Response) [ Time Frame: Every 8 weeks ]
    Imaging tests (CT scan, CXR [Chest X-Ray], MRI or imaging studies as clinically indicated

  2. Response Duration, Time to Treatment Failure, and Time to Progression [ Time Frame: Every 8 weeks ]
    Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated

  3. Toxicity [ Time Frame: First day of each cycle ]
    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

  4. pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation [ Time Frame: At start of study ]
    Tumor tissue collected from paraffin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00376948

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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
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Principal Investigator: Khaldoun Almhanna, MD Barbara Ann Karmanos Cancer Institute
Principal Investigator: Fazlul H. Sarkar, PhD Barbara Ann Karmanos Cancer Institute
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Responsible Party: Barbara Ann Karmanos Cancer Institute Identifier: NCT00376948    
Other Study ID Numbers: CDR0000495776
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2006    Key Record Dates
Results First Posted: August 26, 2014
Last Update Posted: December 4, 2017
Last Verified: October 2017
Keywords provided by Barbara Ann Karmanos Cancer Institute:
adenocarcinoma of the pancreas
stage III pancreatic cancer
stage IV pancreatic cancer
recurrent pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Anticarcinogenic Agents
Protective Agents
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists