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

Phase 2
21 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

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



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


- 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.

Inclusion Criteria


- 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


- 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


- No prior chemotherapy or radiotherapy for metastatic disease

- Prior adjuvant chemotherapy allowed provided it was completed at least 6 months

- No prior gemcitabine hydrochloride or epidermal growth factor receptor-inhibiting

- No other concurrent chemotherapy, immunotherapy, tumor-directed hormonal therapy, or

- No other concurrent investigational agents

- No other concurrent antitumor therapy

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

at 6 months

Safety Issue:


Principal Investigator

Khaldoun Almhanna, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

March 2010

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • recurrent pancreatic cancer
  • Pancreatic Neoplasms



Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009