Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Temporarily closed 21 and over NCI WSU-2005-006 WSU-025806MP4F, NCT00376948

Objectives

Primary

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

Secondary

1. Determine the frequency of objective tumor response rate in these patients.
2. Determine the time to treatment failure in these patients.
3. Determine the effect of baseline expression of pAKT and activation of NF-kappaB on survival of patients treated with this regimen.
4. Determine the overall time to disease progression in these patients.
5. Estimate the quantitative and qualitative toxicities of this regimen in these patients.

Entry 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

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

Patient Characteristics:

• SWOG performance status 0-1
• Life expectancy ≥ 12 weeks
• Platelet count ≥ 100,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• 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

Expected Enrollment

A total of 40 patients will be accrued for this study.

Outcomes

Survival at 6 months
Overall survival

Overall objective response rate (complete and partial response)
Response duration, time to treatment failure, and time to progression
Toxicity
pAKT and NF-kappaB activation

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.

Trial Contact Information

Trial Lead Organizations

Barbara Ann Karmanos Cancer Institute

Basil El-Rayes, MD, Principal investigator		Ph: 313-576-8723; 800-527-6266 Email: elrayesb@karmanos.org
Fazlul Sarkar, PhD, Principal investigator		Ph: 313-576-8327; 800-527-6266

Registry Information
Official Title		Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer
Trial Start Date		2005-05-25
Trial Completion Date		2008-07-25 (estimated)
Registered in ClinicalTrials.gov		NCT00376948
Date Submitted to PDQ		2006-07-25
Information Last Verified		2008-12-15
NCI Grant/Contract Number		CA22453

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