Trial Outcomes & Findings for Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors (NCT NCT00470366)
NCT ID: NCT00470366
Last Updated: 2017-11-28
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
3 years
Results posted on
2017-11-28
Participant Flow
Protocol Open to Accrual 03/27/2007 Protocol Closed to Accrual 8/13/2013 Primary Completion Date 06-13-2016 Recruitment Location is the medical clinic
Participant milestones
| Measure |
Paclitaxel, Ifosfamide, and Cisplatin
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
pegfilgrastim
cisplatin
ifosfamide
paclitaxel
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Paclitaxel, Ifosfamide, and Cisplatin
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
pegfilgrastim
cisplatin
ifosfamide
paclitaxel
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Poor compliance
|
1
|
Baseline Characteristics
Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors
Baseline characteristics by cohort
| Measure |
Paclitaxel, Ifosfamide, and Cisplatin
n=60 Participants
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
pegfilgrastim
cisplatin
ifosfamide
paclitaxel
|
|---|---|
|
Age, Continuous
|
28 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
Outcome measures
| Measure |
Paclitaxel, Ifosfamide, and Cisplatin
n=56 Participants
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
pegfilgrastim
cisplatin
ifosfamide
paclitaxel
|
|---|---|
|
Rate of Complete Response
Complete Response
|
38 Participants
|
|
Rate of Complete Response
PR-Negative
|
7 Participants
|
|
Rate of Complete Response
Incomplete Response
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 8 yearsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Paclitaxel, Ifosfamide, and Cisplatin
n=60 Participants
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
pegfilgrastim
cisplatin
ifosfamide
paclitaxel
|
|---|---|
|
Progression-free Survival
|
4.4 years
Interval 1.0 to 7.6
|
SECONDARY outcome
Timeframe: 3 yearsProgression Free Survival at 3 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Paclitaxel, Ifosfamide, and Cisplatin
n=60 Participants
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
pegfilgrastim
cisplatin
ifosfamide
paclitaxel
|
|---|---|
|
Percentage of Participants With Progression Free Survival
|
72 percentage of patients
Interval 61.0 to 84.0
|
SECONDARY outcome
Timeframe: 3 yearsToxicity evaluated and graded according to the National Cancer Institute, Version 3.0
Outcome measures
| Measure |
Paclitaxel, Ifosfamide, and Cisplatin
n=60 Participants
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
pegfilgrastim
cisplatin
ifosfamide
paclitaxel
|
|---|---|
|
Number of Patients With Treatment Related Toxicity
|
60 Participants
|
Adverse Events
Paclitaxel, Ifosfamide, and Cisplatin
Serious events: 34 serious events
Other events: 60 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Paclitaxel, Ifosfamide, and Cisplatin
n=60 participants at risk
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
pegfilgrastim
cisplatin
ifosfamide
paclitaxel
|
|---|---|
|
Immune system disorders
Allergy/Immunology, other
|
5.0%
3/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Cardiac disorders
Atrial tachycardia/Paroxysmal Atrial Tachycardia
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Cardiac disorders
Cardiac General, other
|
3.3%
2/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Vascular disorders
Chyle or lymph leakage
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Psychiatric disorders
Confusion
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Investigations
Creatinine
|
5.0%
3/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Renal and urinary disorders
Cystitis
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
3/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Nervous system disorders
Dizziness
|
3.3%
2/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
3/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Nervous system disorders
Encephalopathy
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
General disorders
Fatigue
|
3.3%
2/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
15.0%
9/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
General disorders
Fever (in the absence of neutropenia)
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Vascular disorders
Hematoma
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.3%
2/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Gastrointestinal disorders
Hemorrhage, Duodenum
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Gastrointestinal disorders
Hemorrhage, Esophagus
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Vascular disorders
Hypotension
|
8.3%
5/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Infections and infestations
Infection w/ Gr 3/4 Neut, Kidney
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Investigations
Leukocytes
|
10.0%
6/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Gastrointestinal disorders
Nausea
|
21.7%
13/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Investigations
Neutrophils/granulocytes
|
16.7%
10/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Renal and urinary disorders
Obstruction, GU - Ureter
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
3.3%
2/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
3.3%
2/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
General disorders
Pain - Chest/thorax NOS
|
3.3%
2/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
General disorders
Pain - Throat/pharynx/larynx
|
5.0%
3/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Platelets
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Renal and urinary disorders
Renal failure
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Nervous system disorders
Syncope
|
1.7%
1/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Vascular disorders
Thrombosis/embolism
|
6.7%
4/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Gastrointestinal disorders
Vomiting
|
21.7%
13/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
Other adverse events
| Measure |
Paclitaxel, Ifosfamide, and Cisplatin
n=60 participants at risk
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
pegfilgrastim
cisplatin
ifosfamide
paclitaxel
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
31.7%
19/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
General disorders
Fatigue
|
28.3%
17/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
25.0%
15/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Investigations
Leukocytes
|
21.7%
13/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Investigations
Neutrophils/granulocytes
|
21.7%
13/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Investigations
Platelets
|
21.7%
13/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Investigations
ALT
|
18.3%
11/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Nervous system disorders
Neuropathy: sensory
|
18.3%
11/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.3%
11/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
10/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Investigations
AST
|
15.0%
9/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.0%
9/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Investigations
Alkaline phosphatase
|
15.0%
9/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
9/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
13.3%
8/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
13.3%
8/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Investigations
Lymphopenia
|
11.7%
7/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Ear and labyrinth disorders
Tinnitus
|
11.7%
7/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Investigations
Hyperbilirubinemia
|
10.0%
6/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
6/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
6/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Investigations
INR
|
10.0%
6/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
5/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
5/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Investigations
Amylase
|
6.7%
4/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
4/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.7%
4/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Gastrointestinal disorders
Mucositis - oral cavity
|
6.7%
4/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
3/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
3/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.0%
3/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
5.0%
3/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.0%
3/60 • Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
|
Additional Information
Dr. Darren Feldman, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-422-4491
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place