Official Title: “Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer”

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.

Study Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: July 2008

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.

Intervention(s) in this Clinical Trial

• Drug: erlotinib hydrochloride
• Drug: gemcitabine hydrochloride
• Drug: genistein

Primary Measures

• Survival at 6 months
  • Safety Issue?: No
• Overall survival
  • Safety Issue?: No

Secondary Measures

• Overall objective response rate (complete and partial response)
  • Safety Issue?: No
• Response duration, time to treatment failure, and time to progression
  • Safety Issue?: No
• Toxicity
  • Safety Issue?: Yes
• pAKT and NF-kappaB activation
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Overall Clinical Trial Officials and Contacts

Basil El-Rayes, MD Principal Investigator Barbara Ann Karmanos Cancer Institute  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00376948

Study ID Number: CDR0000495776

ClinicalTrials.gov Identifier: NCT00376948

Health Authority: United States: Food and Drug Administration

Clinical trial summary from the National Cancer Institute's PDQ® database