Trial Outcomes & Findings for Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer (NCT NCT01959672)
NCT ID: NCT01959672
Last Updated: 2023-10-10
Results Overview
Rate of progressive disease defined as at least a 25% increase in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. An exact one-sided 90% confidence interval will be constructed round the progressive disease rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Up to 4 months
Results posted on
2023-10-10
Participant Flow
Participant milestones
| Measure |
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.
IMMUNOTHERAPY: Patients with CA125 level \>= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.
STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18.
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|---|---|
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Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.
IMMUNOTHERAPY: Patients with CA125 level \>= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.
STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18.
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|---|---|
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Overall Study
Death
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1
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Baseline Characteristics
Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
n=11 Participants
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.
IMMUNOTHERAPY: Patients with CA125 level \>= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.
STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18.
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|---|---|
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Age, Continuous
|
65 years
n=99 Participants
|
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Sex: Female, Male
Female
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2 Participants
n=99 Participants
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Sex: Female, Male
Male
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9 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
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10 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
Other
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1 Participants
n=99 Participants
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Region of Enrollment
United States
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11 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Up to 4 monthsPopulation: Analysis of the primary endpoint (progression at 4 months) demonstrated that of the ten patients who remained alive, two (20%) had progressed at 4 months.
Rate of progressive disease defined as at least a 25% increase in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. An exact one-sided 90% confidence interval will be constructed round the progressive disease rate.
Outcome measures
| Measure |
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
n=10 Participants
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.
IMMUNOTHERAPY: Patients with CA125 level \>= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.
STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18.
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|---|---|
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Number of Participants With Progressive Disease,
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2 Participants
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SECONDARY outcome
Timeframe: Date of administration study drug to the date of first appearance of tumor lesions by imaging, or death, assessed up to 5 yearsAnalyzed using Kaplan-Meier plots, medians and ranges.
Outcome measures
| Measure |
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
n=11 Participants
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.
IMMUNOTHERAPY: Patients with CA125 level \>= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.
STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18.
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|---|---|
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Distant Failure-free Survival
|
11 months
Interval 7.0 to 15.0
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SECONDARY outcome
Timeframe: Date of first of study drug to the date of death, assessed up to 5 yearsAnalyzed using Kaplan-Meier plots, medians and ranges.
Outcome measures
| Measure |
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
n=11 Participants
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.
IMMUNOTHERAPY: Patients with CA125 level \>= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.
STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18.
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|---|---|
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Overall Survival
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14.4 months
Interval 12.0 to 18.0
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SECONDARY outcome
Timeframe: Up to week 18The percentage of patients who will undergo R0 resection
Outcome measures
| Measure |
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
n=10 Participants
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.
IMMUNOTHERAPY: Patients with CA125 level \>= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.
STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18.
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|---|---|
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Surgical Complete Resection (Negative Margin) Rate
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4 Participants
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SECONDARY outcome
Timeframe: Up to week 18The percentage of patients responding will be summarized using frequencies and percentages. Define poor, intermediate and good response as follows: Score 1-3: poor response to neoadjuvant therapy (still have majority of cancer at the time of surgery) Score 4-6: intermediate response to neoadjuvant therapy (still have moderate amount of cancer at the time of surgery) Score 7-9: good response to neoadjuvant therapy (have minimal amount of residual cancer at the time of surgery)
Outcome measures
| Measure |
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
n=4 Participants
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.
IMMUNOTHERAPY: Patients with CA125 level \>= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.
STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18.
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|---|---|
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Tumor Response Rate, Evaluated on the Pathology Specimen
Pathologic poor response
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2 Participants
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Tumor Response Rate, Evaluated on the Pathology Specimen
Pathologic intermediate response
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1 Participants
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Tumor Response Rate, Evaluated on the Pathology Specimen
Pathologic good response
|
1 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to week 12The percentage of patients responding will be summarized using frequencies and percentages.
Outcome measures
| Measure |
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
n=5 Participants
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.
IMMUNOTHERAPY: Patients with CA125 level \>= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.
STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18.
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|---|---|
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Number of Participants With CA-125-Specific T-cell Signal.
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2 Participants
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Adverse Events
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
Serious events: 6 serious events
Other events: 2 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
n=11 participants at risk
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.
IMMUNOTHERAPY: Patients with CA125 level \>= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.
STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18.
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|---|---|
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Blood and lymphatic system disorders
Anemia
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18.2%
2/11 • Number of events 2 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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Investigations
Leukopenia
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54.5%
6/11 • Number of events 6 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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Investigations
Thrombocytopenia
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36.4%
4/11 • Number of events 4 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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Investigations
Lymphopenia
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36.4%
4/11 • Number of events 4 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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Investigations
Reduced ANC
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18.2%
2/11 • Number of events 2 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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Investigations
Nausea
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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Gastrointestinal disorders
Vomiting
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9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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Investigations
Dehydration
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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Investigations
Depression
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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Renal and urinary disorders
Somnolence
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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|
Gastrointestinal disorders
Hypokalemia
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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Infections and infestations
Hyperkalemia
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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|
Metabolism and nutrition disorders
ALT elevation
|
18.2%
2/11 • Number of events 2 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
|
|
Vascular disorders
AST elevation
|
18.2%
2/11 • Number of events 2 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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|
Investigations
Pancreatitis
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
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Vascular disorders
Pneumonia
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9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Acidosis
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Urinary tract infection
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
|
|
Metabolism and nutrition disorders
Sepsis
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
|
|
Nervous system disorders
Pleural effusion
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
|
|
Cardiac disorders
Sinusitis
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Cardiac disorders
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
|
Other adverse events
| Measure |
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
n=11 participants at risk
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV, leucovorin calcium IV over 30 minutes, and fluorouracil IV over 24 hours on days 1 and 8. Treatment repeats every 3 weeks for 7 courses.
IMMUNOTHERAPY: Patients with CA125 level \>= 10 receive oregovomab IV over 15-30 minutes on day 15. Treatment repeats every 3 weeks for 3 courses (weeks 1, 4, 7) and post- radiation therapy for 1 course (week 14). Patients may receive an additional 3 courses concurrently with chemotherapy upon recovery from surgery based on CA125 level. Patients also receive nelfinavir mesylate PO BID for 5 weeks beginning on day 15 of week 9.
STEREOTACTIC RADIATION THERAPY: Beginning in week 11, patients undergo SBRT in 5 fractions over 5 consecutive days. Upon completion of radiation therapy, patients resume nelfinavir mesylate for 14 days (week 12-13). Patients without metastasis and with resectable disease undergo surgery in week 17-18.
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|---|---|
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Investigations
Orthostasis
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
|
|
Investigations
Rash
|
9.1%
1/11 • Number of events 1 • From the time of informed consent until 30 days after last administration of study medication - approximately 22 weeks
6 of 9 patients experienced any grade ≥3 adverse event
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place