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Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
This study is ongoing, but not recruiting participants.
First Received: September 13, 2006   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00376948
  Purpose

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 Intervention Phase
Pancreatic Cancer
Dietary Supplement: genistein
Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival at 6 months [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall objective response rate (complete and partial response) [ Designated as safety issue: No ]
  • Response duration, time to treatment failure, and time to progression [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • pAKT and NF-kappaB activation [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2005
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 metastases

PATIENT CHARACTERISTICS:

  • SWOG 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 and ALT < 1.5 times upper limit of normal
  • Creatinine < 1.5 mg/dL
  • Albumin > 2.5 g/dL
  • INR < 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376948

Locations
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
Investigators
Principal Investigator: Basil El-Rayes, MD Barbara Ann Karmanos Cancer Institute
Principal Investigator: Fazlul H. Sarkar, PhD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute ( Basil El-Rayes )
Study ID Numbers: CDR0000495776, WSU-2005-006, WSU-025806MP4F
Study First Received: September 13, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00376948     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage III pancreatic cancer
stage IV pancreatic cancer
recurrent pancreatic cancer

Study placed in the following topic categories:
Antimetabolites
Anticarcinogenic Agents
Immunologic Factors
Pancreatic Neoplasms
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Protein Kinase Inhibitors
Pancrelipase
Hormones
Phytoestrogens
Gemcitabine
Endocrine Gland Neoplasms
Erlotinib
Estrogens
Digestive System Neoplasms
Endocrine System Diseases
Antiviral Agents
Immunosuppressive Agents
Recurrence
Digestive System Diseases
Radiation-Sensitizing Agents
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Adenocarcinoma
Genistein

Additional relevant MeSH terms:
Anticarcinogenic Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Protein Kinase Inhibitors
Hormones
Neoplasms by Site
Therapeutic Uses
Phytoestrogens
Gemcitabine
Endocrine Gland Neoplasms
Erlotinib
Estrogens
Digestive System Neoplasms
Endocrine System Diseases
Enzyme Inhibitors
Protective Agents
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Estrogens, Non-Steroidal

ClinicalTrials.gov processed this record on July 02, 2009