Phase 2 N=20 Treatment

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

Pancreatic Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00376948 ↗

Enrolled (actual)

Serious AEs

70.0%

Results posted

Aug 2014

Primary outcome: Primary: Patients Alive — 10 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: genistein (Dietary_supplement); erlotinib hydrochloride (Drug); gemcitabine hydrochloride (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Barbara Ann Karmanos Cancer Institute
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Patients Alive	10	—
PRIMARY Median Overall Survival Estimate	6.3	—
SECONDARY Overall Objective Response Rate (Complete and Partial Response)	0.056	—
SECONDARY Response Duration	73	—
SECONDARY Time to Treatment Failure	2.04	—
SECONDARY Time to Progression	2.07	—
SECONDARY Grade 3 or Higher Toxicity Evaluation	3; 5; 1; 7; 4; 5	—
SECONDARY pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation	—	—

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 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.

Eligibility 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 (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 2.5 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00376948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.