Status:
COMPLETED
Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
21-120 years
Phase:
PHASE2
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 ...
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 hydrochlo...
Eligibility Criteria
Inclusion
- 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 (central nervous system) metastases
- PATIENT CHARACTERISTICS:
- 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
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00376948
Start Date
May 1 2005
End Date
March 1 2010
Last Update
March 1 2021
Active Locations (2)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
2
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009