Trial · NCT00376948
Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
NCT00376948, Phase 2, Completed, Barbara Ann Karmanos Cancer Institute; results first posted 2014-08-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer. Trials, record NCT00376948. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00376948
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
- NCT number
- NCT00376948
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Conditions
- Pancreatic Cancer
- Interventions
- genistein, erlotinib hydrochloride, gemcitabine hydrochloride
- First posted
- 2006-09-15
- Last updated
- 2021-03-01
- Results first posted
- 2014-08-26
- Limitations and caveats
- This study was stopped early due to the lack of efficacy.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients Alive | at 6 months | |
| Primary | Median Overall Survival Estimate | up to 17 months | |
| Secondary | Overall Objective Response Rate (Complete and Partial Response) | Every 8 weeks | Imaging tests (CT scan, CXR \[Chest X-Ray\], MRI or imaging studies as clinically indicated |
| Secondary | Response Duration | Every 8 weeks | Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions. Partial response is defined as greater than or equal to 30% reduction in the sum of the longest diameteres of target lesions, taking as reference the baseline sum of the longest diameters. |
| Secondary | Time to Treatment Failure | Every 8 weeks | Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions. |
| Secondary | Time to Progression | Every 8 weeks | Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions. |
| Secondary | Grade 3 or Higher Toxicity Evaluation | First day of each cycle | Toxicity evaluation using NCI-CTC (Common Terminology Criteria) v.3 criteria; CBC (complete blood count) with differential white cell and platelet counts; Serum sodium, potassium, chloride, bicarbonate, AST, ALT, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, and albumin; Serum CA 19-9 |
| Secondary | pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation | At start of study | Tumor tissue collected from paraffin |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patients Alive | at 6 months | participants | NUMBER | |
| PRIMARY | Median Overall Survival Estimate | up to 17 months | months | MEDIAN | |
| SECONDARY | Overall Objective Response Rate (Complete and Partial Response) | Every 8 weeks | proportion of patients | NUMBER | |
| SECONDARY | Response Duration | Every 8 weeks | days | NUMBER | |
| SECONDARY | Time to Treatment Failure | Every 8 weeks | months | MEDIAN | |
| SECONDARY | Time to Progression | Every 8 weeks | moths | MEDIAN | |
| SECONDARY | Grade 3 or Higher Toxicity Evaluation | First day of each cycle | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation | At start of study | Data not collected |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patients Alive | Novasoy®, Gemcitabine & Erlotinib | 10 | participants | ||
| Median Overall Survival Estimate | Novasoy®, Gemcitabine & Erlotinib | 6.3 | 90% Confidence Interval 4.6 to 12.6 | months | |
| Overall Objective Response Rate (Complete and Partial Response) | Novasoy®, Gemcitabine & Erlotinib | 0.056 | 90% Confidence Interval 0.012 to 0.215 | proportion of patients | |
| Response Duration | Novasoy®, Gemcitabine & Erlotinib | 73 | days | ||
| Time to Treatment Failure | Novasoy®, Gemcitabine & Erlotinib | 2.04 | 90% Confidence Interval 1.74 to 3.48 | months | |
| Time to Progression | Novasoy®, Gemcitabine & Erlotinib | 2.07 | 90% Confidence Interval 2.04 to 8.34 | moths | |
| Grade 3 or Higher Toxicity Evaluation | Novasoy®, Gemcitabine & Erlotinib | diarrhea | 3 | Participants | |
| Grade 3 or Higher Toxicity Evaluation | Novasoy®, Gemcitabine & Erlotinib | fatigue | 5 | Participants | |
| Grade 3 or Higher Toxicity Evaluation | Novasoy®, Gemcitabine & Erlotinib | infection | 1 | Participants | |
| Grade 3 or Higher Toxicity Evaluation | Novasoy®, Gemcitabine & Erlotinib | nausea | 7 | Participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Novasoy®, Gemcitabine & Erlotinib | 20 | |
| Overall Study | COMPLETED | Novasoy®, Gemcitabine & Erlotinib | 20 | |
| Overall Study | NOT COMPLETED | Novasoy®, Gemcitabine & Erlotinib | 0 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Novasoy®, Gemcitabine & Erlotinib | 11 | 20 | 11 |
| other | Fatigue | General disorders | Novasoy®, Gemcitabine & Erlotinib | 8 | 20 | 8 |
| other | Hemoglobin | Blood and lymphatic system disorders | Novasoy®, Gemcitabine & Erlotinib | 15 | 20 | 15 |
| other | Pain | General disorders | Novasoy®, Gemcitabine & Erlotinib | 7 | 20 | 7 |
| other | Platelet | Investigations | Novasoy®, Gemcitabine & Erlotinib | 15 | 20 | 15 |
| other | Skin rash | Skin and subcutaneous tissue disorders | Novasoy®, Gemcitabine & Erlotinib | 15 | 20 | 15 |
| other | Stomach, mucositis | Gastrointestinal disorders | Novasoy®, Gemcitabine & Erlotinib | 4 | 20 | 4 |
| other | Vomiting | Gastrointestinal disorders | Novasoy®, Gemcitabine & Erlotinib | 4 | 20 | 4 |
| other | Neutrophil | Blood and lymphatic system disorders | Novasoy®, Gemcitabine & Erlotinib | 7 | 20 | 7 |
| other | WBC (white blood count) | Blood and lymphatic system disorders | Novasoy®, Gemcitabine & Erlotinib | 7 | 20 | 7 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Novasoy®, Gemcitabine & Erlotinib | ||
| Total, other adverse events | Novasoy®, Gemcitabine & Erlotinib | 15 | 20 |
| Total, serious adverse events | Novasoy®, Gemcitabine & Erlotinib | 14 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA022453 | CANCER CENTER SUPPORT GRANT | PASCHE, BORIS | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00376948
GET https://conductscience.org/api/trials/v1/NCT00376948/events?page=2