Trial Outcomes & Findings for Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma (NCT NCT01360593)
NCT ID: NCT01360593
Last Updated: 2022-03-08
Results Overview
LPFS is defined as the time from enrollment to first documentation of progressive disease (PD) in the target lesion. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume. Death or development of distant disease is not regarded as an event. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, progressive disease is 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.
COMPLETED
PHASE2
35 participants
Up to 32 months
2022-03-08
Participant Flow
Participant milestones
| Measure |
Gem + Xeloda + SBRT
Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day.
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|---|---|
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Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Gem + Xeloda + SBRT
n=34 Participants
Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day.
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|---|---|
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Age, Continuous
|
70.49 years
STANDARD_DEVIATION 7.66 • n=99 Participants
|
|
Sex: Female, Male
Female
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20 Participants
n=99 Participants
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Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
ECOG Performance Status
ECOG Score of 0
|
14 Participants
n=99 Participants
|
|
ECOG Performance Status
ECOG Score of 1
|
20 Participants
n=99 Participants
|
|
Karnofsky Performance Status
|
89.12 units on a scale
STANDARD_DEVIATION 9.65 • n=99 Participants
|
|
Body Mass Index (BMI)
|
27.10 kg/m^2
STANDARD_DEVIATION 8.8 • n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 32 monthsPopulation: Patients able to be evaluated for response after study treatment.
LPFS is defined as the time from enrollment to first documentation of progressive disease (PD) in the target lesion. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume. Death or development of distant disease is not regarded as an event. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, progressive disease is 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.
Outcome measures
| Measure |
Gem + Xeloda + SBRT
n=34 Participants
Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day.
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|---|---|
|
Local Progression-free Survival (LPFS)
|
22.30801 months
Interval 17.31417 to
Upper bound of 95% CI not reached due to insufficient number of participants with events.
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SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Patients receiving neoadjuvant chemotherapy.
Percentage of participants with response per RECIST v1.0. Per RECIST v1.0: Complete Response (CR): the disappearance of a lesion; Near Complete Response (NCR): at least an 80% decrease in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. Partial Response (PR): at least a 30% decrease in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started.
Outcome measures
| Measure |
Gem + Xeloda + SBRT
n=31 Participants
Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day.
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|---|---|
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Objective Response Rate (ORR) (Neoadjuvant Chemotherapy)
|
28.13 percentage of participants
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SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Patients treated with surgery after chemotherapy and SBRT.
Percentage of participants with response per RECIST v1.0. Per RECIST v1.0: Complete Response (CR): the disappearance of a lesion; Near Complete Response (NCR): at least an 80% decrease in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. Partial Response (PR): at least a 30% decrease in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started.
Outcome measures
| Measure |
Gem + Xeloda + SBRT
n=10 Participants
Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day.
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|---|---|
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Objective Response Rate (ORR) (Surgery After Chemotherapy and SBRT)
|
20.0 percentage of participants
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SECONDARY outcome
Timeframe: Up to 32 monthsPopulation: Patients that received study treatment.
The (median) length of time from enrollment to confirmed death from any cause.
Outcome measures
| Measure |
Gem + Xeloda + SBRT
n=34 Participants
Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day.
|
|---|---|
|
Overall Survival (OS)
|
18.82546 months
Interval 13.86448 to
Upper bound of 95% CI not reached due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients that received study treatment.
The (median) length of time from enrollment to disease progression per Response Evaluation Criteria in Solid Tumors (v1.0). Per RECIST, Progressive Disease (PD) is defined at least a 25% increase in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. For lesions without size response the maintenance of CA 19-9 level above the normal limits indicates disease progression.
Outcome measures
| Measure |
Gem + Xeloda + SBRT
n=34 Participants
Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day.
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|---|---|
|
Time to Progression (TTP)
|
16 months
Interval 8.375 to 23.625
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SECONDARY outcome
Timeframe: Baseline; 2 - 4 weeks post chemotherapy; 4-6 weeks post SBRT; after surgery (up to 24 months)Population: Treated patients that completed FACT/Quality of Life surveys.
The Functional Assessment of Cancer Therapy - General (FACT-G) is a self-administered, 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Quality of Life (QOL) evaluation will be administered prior to SBRT, after completion of SBRT, and at each follow-up. Scaling of items: Five-point scale for each questions from 0 (not at all) to 4 (very much); overall scoring 0-108. Higher scores indicated better quality of life.
Outcome measures
| Measure |
Gem + Xeloda + SBRT
n=34 Participants
Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day.
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|---|---|
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The Functional Assessment of Cancer Therapy - General (FACT-G)
4-6 weeks after SBRT
|
51.5 score on a scale
Interval 0.0 to 67.0
|
|
The Functional Assessment of Cancer Therapy - General (FACT-G)
Baseline
|
54.0 score on a scale
Interval 52.0 to 57.0
|
|
The Functional Assessment of Cancer Therapy - General (FACT-G)
2-4 weeks after Chemo
|
54.0 score on a scale
Interval 0.0 to 62.0
|
|
The Functional Assessment of Cancer Therapy - General (FACT-G)
after Surgery, up to 24 months
|
49.5 score on a scale
Interval 0.0 to 61.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Patients that received study treatment with resection after neoadjuvant therapy.
Number of patients that are able to undergo a margin-negative resection after neoadjuvant therapy. Surgical evaluation: pathology records reviewed by operating surgeon to determine margin status as negative (not close (1-2.5mm), microscopically positive, and/or grossly positive).
Outcome measures
| Measure |
Gem + Xeloda + SBRT
n=35 Participants
Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day.
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|---|---|
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Number of Participants Able to Undergo a Margin-negative Resection After Neoadjuvant Therapy
|
11 Participants
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SECONDARY outcome
Timeframe: Up to 3 months following SBRT treatmentPopulation: Patients that received SBRT.
Percentage of patients that experience treatment-related toxicities as graded according to Common Terminology Criteria for Adverse Events (CTCAE v4), within 3 months after treatment, by grade. Patients were monitored for potential toxicity throughout treatment.
Outcome measures
| Measure |
Gem + Xeloda + SBRT
n=34 Participants
Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day.
|
|---|---|
|
Acute Toxicities Associated With SBRT
Grade 1
|
88.24 percentage of participants
|
|
Acute Toxicities Associated With SBRT
Grade 2
|
29.41 percentage of participants
|
|
Acute Toxicities Associated With SBRT
Grade 3
|
14.71 percentage of participants
|
|
Acute Toxicities Associated With SBRT
Grade 4
|
2.94 percentage of participants
|
SECONDARY outcome
Timeframe: From 3 months following SBRT treatment up to 24 monthsPopulation: Patients that received study treatment.
Percentage of patients that experience treatment-related toxicities as graded according to Common Terminology Criteria for Adverse Events (CTCAE v4), greater than 3 months after treatment, by grade. Patients were monitored for potential toxicity throughout treatment.
Outcome measures
| Measure |
Gem + Xeloda + SBRT
n=35 Participants
Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day.
|
|---|---|
|
Late Toxicities Associated With SBRT
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Due to a lack of insurance coverage for PET-CT in the context of pancreatic cancer, most insurers denied PET- CT in these patients, as such and to prevent any undue burden on patients, FDG-PET scans were not performed
18F-FDG response measured using European Organization for Research and Treatment of Cancer (EORTC) 1999. Number of patients with non-FDG avid tumors with response to therapy using semi-quantitative SUV (standard uptake value) analysis based on lean body mass and/or body surface area is used in determining 18F-FDG uptake. \[18F\]-FDG uptake may provide an early, indication of the tumoricidal effect of anticancer agents.
Outcome measures
Outcome data not reported
Adverse Events
Gem + Xeloda + SBRT
Serious adverse events
| Measure |
Gem + Xeloda + SBRT
n=34 participants at risk
Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
5.9%
2/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
Investigations
White blood cell decreased ( leukopenia)
|
5.9%
2/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
Infections and infestations
Abdominal Infection
|
2.9%
1/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
Gastrointestinal disorders
Ileus
|
2.9%
1/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
Injury, poisoning and procedural complications
Bleeding
|
2.9%
1/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
Nervous system disorders
Stroke
|
2.9%
1/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
Other adverse events
| Measure |
Gem + Xeloda + SBRT
n=34 participants at risk
Gemcitabine administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Capecitabine taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Fractionated Stereotactic Body Radiation Therapy (SBRT) delivered to patients that have stable disease, partial response, or complete response after chemo as 12 Gy x 3 fractions (36 Gy total) - Given every other day.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
17.6%
6/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
Blood and lymphatic system disorders
Anemia
|
20.6%
7/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
Hepatobiliary disorders
Liver Dysfunction
|
11.8%
4/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
Infections and infestations
Hand-Foot
|
8.8%
3/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
Investigations
White blood cell decreased ( leukopenia)
|
14.7%
5/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.7%
5/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
Gastrointestinal disorders
Diarrhea
|
14.7%
5/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
General disorders
Edema
|
2.9%
1/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
Injury, poisoning and procedural complications
Dermatitis
|
2.9%
1/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
General disorders
Mucositis
|
2.9%
1/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
|
Investigations
Platelet count decreased ( Thrombocytopenia)
|
2.9%
1/34 • Up to 32 months for the study population.
Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities.
|
Additional Information
Barbara Stadterman, Regulatory Supervisor, MPH, CCRP
UPMC Hillman Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place