Clinical trialPhase 2Completed
Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- May 2005
- Expected end
- March 2010
- Enrollment
- 20 participants
- Sites
- 2
- Primary outcomes
- Patients Alive; Median Overall Survival Estimate
- Sponsor
- Other
- Results posted
- 2014-08-26
- Last update
- 1 March 2021
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Patients Alive [at 6 months]. Number, participants. Novasoy®, Gemcitabine & Erlotinib (n=20): 10.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Median Overall Survival Estimate [up to 17 months]. Median, months (90% Confidence Interval). Novasoy®, Gemcitabine & Erlotinib (n=20): 6.3 (4.6 to 12.6).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Objective Response Rate (Complete and Partial Response) [Every 8 weeks]. Number, proportion of patients (90% Confidence Interval). Novasoy®, Gemcitabine & Erlotinib (n=18): 0.056 (0.012 to 0.215).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Duration [Every 8 weeks]. Number, days. Novasoy®, Gemcitabine & Erlotinib (n=1): 73.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Treatment Failure [Every 8 weeks]. Median, months (90% Confidence Interval). Novasoy®, Gemcitabine & Erlotinib (n=17): 2.04 (1.74 to 3.48).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Progression [Every 8 weeks]. Median, moths (90% Confidence Interval). Novasoy®, Gemcitabine & Erlotinib (n=19): 2.07 (2.04 to 8.34).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Grade 3 or Higher Toxicity Evaluation [First day of each cycle]. Count Of Participants, Participants. diarrhea: Novasoy®, Gemcitabine & Erlotinib (n=20): 3. fatigue: Novasoy®, Gemcitabine & Erlotinib (n=20): 5. infection: Novasoy®, Gemcitabine & Erlotinib (n=20): 1. nausea: Novasoy®, Gemcitabine & Erlotinib (n=20): 7. neutrophil: Novasoy®, Gemcitabine & Erlotinib (n=20): 4. pain: Novasoy®, Gemcitabine & Erlotinib (n=20): 5. platelet: Novasoy®, Gemcitabine & Erlotinib (n=20): 1. stomach mucostis: Novasoy®, Gemcitabine & Erlotinib (n=20): 1. vomiting: Novasoy®, Gemcitabine & Erlotinib (n=20): 4. wbc: Novasoy®, Gemcitabine & Erlotinib (n=20): 2. other toxicity: Novasoy®, Gemcitabine & Erlotinib (n=20): 4.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation [At start of study].