Trial Outcomes & Findings for Pemetrexed Plus Gemcitabine or Carboplatin for Patients With Advanced Malignant Pleural Mesothelioma (NCT NCT00101283)
NCT ID: NCT00101283
Last Updated: 2023-07-03
Results Overview
Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression
Results posted on
2023-07-03
Participant Flow
The study was activated on November 1, 2005, accrued its first patient on February 23, 2006, suspended to accrual on July 12, 2007 for response evaluation, and closed to accrual on April 1, 2008.
Participant milestones
| Measure |
Pemetrexed/Carboplatin
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
|
Pemetrexed/Gemcitabine
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
Began Treatment
|
16
|
13
|
|
Overall Study
COMPLETED
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Pemetrexed/Carboplatin
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
|
Pemetrexed/Gemcitabine
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Insurance Refusal
|
0
|
1
|
|
Overall Study
Prostate Cancer Recurrence
|
0
|
1
|
Baseline Characteristics
Pemetrexed Plus Gemcitabine or Carboplatin for Patients With Advanced Malignant Pleural Mesothelioma
Baseline characteristics by cohort
| Measure |
Pemetrexed/Carboplatin
n=16 Participants
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
|
Pemetrexed/Gemcitabine
n=13 Participants
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
68 years
n=7 Participants
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progressionPopulation: The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.
Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression.
Outcome measures
| Measure |
Pemetrexed/Carboplatin
n=16 Participants
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
|
Pemetrexed/Gemcitabine
n=13 Participants
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
|
|---|---|---|
|
Best Overall Response by RECIST Criteria (Version 1.0)
Partial Response
|
3 eligible, treated participants
|
0 eligible, treated participants
|
|
Best Overall Response by RECIST Criteria (Version 1.0)
Stable Disease
|
7 eligible, treated participants
|
6 eligible, treated participants
|
|
Best Overall Response by RECIST Criteria (Version 1.0)
Progression
|
5 eligible, treated participants
|
5 eligible, treated participants
|
|
Best Overall Response by RECIST Criteria (Version 1.0)
Unevaluable
|
1 eligible, treated participants
|
2 eligible, treated participants
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 1 yearPopulation: The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.
Time from randomization to death. Patients alive at last follow-up were censored.
Outcome measures
| Measure |
Pemetrexed/Carboplatin
n=16 Participants
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
|
Pemetrexed/Gemcitabine
n=13 Participants
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
|
|---|---|---|
|
Overall Survival
|
13.0 Months
Interval 5.6 to 21.9
|
6.0 Months
Interval 3.9 to 14.0
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 1 yearPopulation: The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.
Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.
Outcome measures
| Measure |
Pemetrexed/Carboplatin
n=16 Participants
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
|
Pemetrexed/Gemcitabine
n=13 Participants
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
|
|---|---|---|
|
Progression-Free Survival
|
4.1 Months
Interval 1.7 to 6.6
|
3.3 Months
Interval 1.6 to 5.2
|
Adverse Events
Pemetrexed/Carboplatin
Serious events: 10 serious events
Other events: 16 other events
Deaths: 0 deaths
Pemetrexed/Gemcitabine
Serious events: 13 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed/Carboplatin
n=16 participants at risk
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
|
Pemetrexed/Gemcitabine
n=13 participants at risk
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
18.8%
3/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
76.9%
10/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.8%
3/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
92.3%
12/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
2/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
12.5%
2/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
23.1%
3/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Elevated bilirubin
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Arachnoiditis/meningismus/radiculitis
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chest/thoracic pain
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
Other adverse events
| Measure |
Pemetrexed/Carboplatin
n=16 participants at risk
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
|
Pemetrexed/Gemcitabine
n=13 participants at risk
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.5%
2/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
68.8%
11/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
61.5%
8/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
56.2%
9/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
53.8%
7/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
93.8%
15/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
92.3%
12/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fever w/o neutropenia
|
18.8%
3/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
23.1%
3/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Insomnia
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
23.1%
3/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Rigors/chills
|
12.5%
2/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Sweating
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Weight gain
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Weight loss
|
18.8%
3/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
38.5%
5/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritis/itching
|
12.5%
2/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
23.1%
3/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
31.2%
5/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
38.5%
5/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Skin - other
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Endocrine disorders
Hot flashes
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Anorexia
|
31.2%
5/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
69.2%
9/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
6/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
38.5%
5/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
18.8%
3/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom), oral cavity
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom), pharynx
|
31.2%
5/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
56.2%
9/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
30.8%
4/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Taste disturbance
|
18.8%
3/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
23.1%
3/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
30.8%
4/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
GI - other
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Colitis, infectious
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/ gr 0-2 neutrophils, sinus
|
12.5%
2/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Edema, limb
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
23.1%
3/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.8%
3/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
84.6%
11/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Elevated alkaline phosphatase
|
18.8%
3/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
69.2%
9/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Elevated ALT, SGPT (serum glutamic pyruvic transaminase)
|
31.2%
5/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
46.2%
6/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Elevated AST, SGOT (serum glutamic oxaloacetic transaminase)
|
18.8%
3/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
46.2%
6/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Elevated bilirubin
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Elevated creatinine
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
4/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue - other
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Depression
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy, sensory
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Eye disorders
Tearing
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Eye disorders
Ocular - other
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Abdomen, pain
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chest/thoracic pain
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Extremity - limb, pain
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Hepatobiliary disorders
Liver, pain
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
12.5%
2/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
4/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
30.8%
4/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Vascular - other
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Immune system disorders
Allergic rhinitis
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Ear and labyrinth disorders
Hearing loss (without baseline audiogram, not in monitoring program)
|
6.2%
1/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
87.5%
14/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
92.3%
12/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
81.2%
13/16 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
84.6%
11/13 • Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place