Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 120 |
| Updated: | 12/6/2017 |
| Start Date: | May 2005 |
| End Date: | March 2010 |
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.
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.
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.
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.
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
We found this trial at
2
sites
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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