Trial Outcomes & Findings for Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer (NCT NCT00065182)
NCT ID: NCT00065182
Last Updated: 2019-06-24
Results Overview
Overall survival was defined as the time from randomization to death and it occurs when all randomized participants had at least one year of follow-up past their date of randomization to treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
399 participants
Primary outcome timeframe
Up to one year from Day -1 (randomization)
Results posted on
2019-06-24
Participant Flow
This was a multicenter study conducted at 62 centers: 11 in Canada, 5 in Poland, and 46 in the United States from 14 August 2003 to 30 August 2007. A total of 399 participants with advanced non-small cell lung cancer (NSCLC) were enrolled in the study and randomized to treatment.
Based on the interim analysis results, the independent data monitoring committee (IDMC) recommended termination of the combination group due to increased toxicity as well as a low likelihood of demonstrating an overall survival benefit at the final analysis.
Participant milestones
| Measure |
IV Topotecan + IV Docetaxel
Eligible participants received intravenous (IV) topotecan 3.5 milligrams per square meter per day (mg/m\^2/day) and IV docetaxel 30 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
IV Docetaxel
Eligible participants received single-agent IV docetaxel administered either 75 mg/m\^2/day Day 1 (± 2 days) of each 21 day treatment cycle or 35 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
|---|---|---|
|
Overall Study
STARTED
|
202
|
197
|
|
Overall Study
COMPLETED
|
154
|
160
|
|
Overall Study
NOT COMPLETED
|
48
|
37
|
Reasons for withdrawal
| Measure |
IV Topotecan + IV Docetaxel
Eligible participants received intravenous (IV) topotecan 3.5 milligrams per square meter per day (mg/m\^2/day) and IV docetaxel 30 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
IV Docetaxel
Eligible participants received single-agent IV docetaxel administered either 75 mg/m\^2/day Day 1 (± 2 days) of each 21 day treatment cycle or 35 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
24
|
17
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
|
Overall Study
Protocol Violation
|
3
|
4
|
|
Overall Study
Serious adverse events (SAE)
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
11
|
7
|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
|
Overall Study
No clinical benefit
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Decline in Status
|
0
|
1
|
Baseline Characteristics
Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
IV Topotecan + IV Docetaxel
n=202 Participants
Eligible participants received IV topotecan 3.5 mg/m\^2/day and IV docetaxel 30 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
IV Docetaxel
n=197 Participants
Eligible participants received single-agent IV docetaxel administered either 75 mg/m\^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-40
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Customized
41-64
|
129 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Age, Customized
>=65
|
69 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
184 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
367 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to one year from Day -1 (randomization)Population: Intent-to-treat (ITT) population was defined as all participants randomized to one of the two treatment regimens.
Overall survival was defined as the time from randomization to death and it occurs when all randomized participants had at least one year of follow-up past their date of randomization to treatment.
Outcome measures
| Measure |
IV Topotecan + IV Docetaxel
n=202 Participants
Eligible participants received IV topotecan 3.5 mg/m\^2/day and IV docetaxel 30 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
IV Docetaxel
n=197 Participants
Eligible participants received single-agent IV docetaxel administered either 75 mg/m\^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
|---|---|---|
|
Median Time of Overall Survival
|
30.7 Weeks
Interval 26.1 to 35.9
|
28.6 Weeks
Interval 23.6 to 36.4
|
SECONDARY outcome
Timeframe: Up to one year from Day -1 (randomization)Population: ITT population. Data was not collected for this outcome measure.
Number of participants with one-year survival were planned to be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one year from Day -1 (randomization)Population: ITT population. Data was not collected for this outcome measure.
Time to progression is defined as the time between randomization and the first radiologically or clinically documented evidence of progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one year from Day -1 (randomization)Population: ITT population. Data was not collected for this outcome measure.
Response rate is defined as the percentage of participants in the ITT population attaining an overall best response of complete or partial response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one year from Day -1 (randomization)Population: ITT population. Data was not collected for this outcome measure.
Response duration is defined as the time from initial radiologically documented response to the first radiologically or clinically documented sign of progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 Weeks post randomizationPopulation: ITT population. Data was not collected for this outcome measure.
Time to response is defined as the time between randomization and the first radiologically documented complete or partial response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 4 Weeks post randomizationPopulation: ITT population. Data was not collected for this outcome measure.
The effect of treatment regimens on participants-perceived disease status and well-being was assessed using Lung Cancer Symptom Scale (LCSS) that consists of 9 items addressing the time frame of past day: 6 measuring major symptoms for lung malignancies (loss of appetite, fatigue, cough, dyspnea, hemoptysis and pain) and 3 summation items related to total symptomatic distress, activity status and global quality of life. All items are measured by visual analogue scales (VAS) which uses 100 millimeter (mm) lines to determine the intensity of participant responses. The lowest level of symptom intensity or functional disability on the VAS is on left (none) and highest intensity is on right (as much as could be).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 16 monthsPopulation: mITT Population was defined as all participants who were randomized and received at least one dose of study medication.
AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or it is considered to be medically significant.
Outcome measures
| Measure |
IV Topotecan + IV Docetaxel
n=200 Participants
Eligible participants received IV topotecan 3.5 mg/m\^2/day and IV docetaxel 30 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
IV Docetaxel
n=195 Participants
Eligible participants received single-agent IV docetaxel administered either 75 mg/m\^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs
|
186 Participants
|
172 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAEs
|
58 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Up to 16 monthsPopulation: mITT population. Only those participants available at the indicated time points were analyzed.
Hematology parameters included hemoglobin, hematocrit, red blood cell count, white blood cell count with differential leukocyte and platelet count. Differential to include total neutrophils, bands, lymphocytes, monocytes, eosinophil, and basophils. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 1, 2, 3 or 4 hematologic toxicities have been presented.
Outcome measures
| Measure |
IV Topotecan + IV Docetaxel
n=200 Participants
Eligible participants received IV topotecan 3.5 mg/m\^2/day and IV docetaxel 30 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
IV Docetaxel
n=195 Participants
Eligible participants received single-agent IV docetaxel administered either 75 mg/m\^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
|---|---|---|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
White blood cell, Grade 2
|
51 Participants
|
14 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
White blood cell, Grade 3
|
50 Participants
|
13 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
Platelets, Grade 1
|
75 Participants
|
10 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
Platelets, Grade 2
|
20 Participants
|
3 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
Platelets, Grade 3
|
18 Participants
|
0 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
Platelets, Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
White blood cell, Grade 1
|
38 Participants
|
28 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
Hemoglobin, Grade 1
|
76 Participants
|
107 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
Hemoglobin, Grade 2
|
95 Participants
|
46 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
Hemoglobin, Grade 3
|
18 Participants
|
11 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
Neutrophils, Grade 1
|
27 Participants
|
14 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
Neutrophils, Grade 2
|
37 Participants
|
7 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
Neutrophils, Grade 3
|
47 Participants
|
7 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
Neutrophils, Grade 4
|
20 Participants
|
11 Participants
|
|
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
White blood cell, Grade 4
|
15 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 16 monthsPopulation: mITT population. Only those participants available at the indicated time points were analyzed.
Standard chemistry evaluation included sodium, potassium, chloride, bicarbonate, calcium, phosphorous, magnesium, blood urea nitrogen (BUN)/urea, uric acid, creatinine, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, total protein and albumin. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 3 or 4 clinical chemical toxicities have been presented.
Outcome measures
| Measure |
IV Topotecan + IV Docetaxel
n=200 Participants
Eligible participants received IV topotecan 3.5 mg/m\^2/day and IV docetaxel 30 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
IV Docetaxel
n=195 Participants
Eligible participants received single-agent IV docetaxel administered either 75 mg/m\^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
|---|---|---|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
Albumin, Grade 3
|
3 Participants
|
3 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
BUN/Urea, Grade 3
|
4 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
Creatinine, Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
Alkaline Phosphatase, Grade 3
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
AST, Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
AST, Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
ALT, Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
ALT, Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
Bilirubin, Grade 3
|
1 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
Sodium, Grade 3
|
12 Participants
|
9 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
Sodium, Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
Calcium, Grade 3
|
2 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
Calcium, Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
Potassium, Grade 3
|
7 Participants
|
3 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
Potassium, Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
Magnesium, Grade 3
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 16 monthsPopulation: mITT population.
Vital sign parameters included (blood pressure, and pulse rate after five minutes sitting, body temperature). Blood pressure and pulse rate was measured after sitting for 5 minutes. Only participants with clinically significant abnormal Vital sign data was reported.
Outcome measures
| Measure |
IV Topotecan + IV Docetaxel
n=200 Participants
Eligible participants received IV topotecan 3.5 mg/m\^2/day and IV docetaxel 30 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
IV Docetaxel
n=195 Participants
Eligible participants received single-agent IV docetaxel administered either 75 mg/m\^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Vital Signs Data
|
0 Participants
|
0 Participants
|
Adverse Events
IV Topotecan + IV Docetaxel
Serious events: 58 serious events
Other events: 181 other events
Deaths: 170 deaths
IV Docetaxel
Serious events: 49 serious events
Other events: 166 other events
Deaths: 165 deaths
Serious adverse events
| Measure |
IV Topotecan + IV Docetaxel
n=200 participants at risk
Eligible participants received IV topotecan 3.5 mg/m\^2/day and IV docetaxel 30 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
IV Docetaxel
n=195 participants at risk
Eligible participants received single-agent IV docetaxel administered either 75 mg/m\^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
3.5%
7/200 • Up to 16 months
mITT population was analyzed for safety data.
|
2.1%
4/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
6/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
6/200 • Up to 16 months
mITT population was analyzed for safety data.
|
1.0%
2/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
6/200 • Up to 16 months
mITT population was analyzed for safety data.
|
3.6%
7/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
5/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
3/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
3/200 • Up to 16 months
mITT population was analyzed for safety data.
|
1.0%
2/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
3/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Infections and infestations
Bronchitis
|
1.0%
2/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
2/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.0%
2/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Infections and infestations
Respiratory tract infection
|
1.0%
2/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
General disorders
Asthenia
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Cardiac disorders
Atrial flutter
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Infections and infestations
Bronchopneumonia
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
General disorders
Catheter related complication
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
General disorders
Disease progression
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Immune system disorders
Drug hypersensitivity
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Investigations
Electrocardiogram ST-T change
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Infections and infestations
Empyema
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Vascular disorders
Haemorrhage
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
General disorders
Infusion site phlebitis
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Nausea
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
1.0%
2/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Infections and infestations
Pharyngitis
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
General disorders
Pyrexia
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Infections and infestations
Sepsis
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
1.0%
2/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Vascular disorders
Shock
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.00%
0/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
1/200 • Up to 16 months
mITT population was analyzed for safety data.
|
1.0%
2/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
2.1%
4/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
1.0%
2/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
1.0%
2/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
General disorders
Oedema
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Perforated ulcer
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/200 • Up to 16 months
mITT population was analyzed for safety data.
|
0.51%
1/195 • Up to 16 months
mITT population was analyzed for safety data.
|
Other adverse events
| Measure |
IV Topotecan + IV Docetaxel
n=200 participants at risk
Eligible participants received IV topotecan 3.5 mg/m\^2/day and IV docetaxel 30 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
IV Docetaxel
n=195 participants at risk
Eligible participants received single-agent IV docetaxel administered either 75 mg/m\^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m\^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
|
|---|---|---|
|
General disorders
Fatigue
|
45.0%
90/200 • Up to 16 months
mITT population was analyzed for safety data.
|
37.9%
74/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
General disorders
Oedema peripheral
|
14.0%
28/200 • Up to 16 months
mITT population was analyzed for safety data.
|
15.9%
31/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
General disorders
Pyrexia
|
15.5%
31/200 • Up to 16 months
mITT population was analyzed for safety data.
|
14.4%
28/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
General disorders
Asthenia
|
9.5%
19/200 • Up to 16 months
mITT population was analyzed for safety data.
|
10.8%
21/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
General disorders
Chest pain
|
8.5%
17/200 • Up to 16 months
mITT population was analyzed for safety data.
|
9.7%
19/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
General disorders
Oedema
|
4.0%
8/200 • Up to 16 months
mITT population was analyzed for safety data.
|
5.1%
10/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
General disorders
Mucosal inflammation
|
5.5%
11/200 • Up to 16 months
mITT population was analyzed for safety data.
|
3.1%
6/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Nausea
|
28.5%
57/200 • Up to 16 months
mITT population was analyzed for safety data.
|
22.1%
43/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.5%
51/200 • Up to 16 months
mITT population was analyzed for safety data.
|
20.5%
40/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Constipation
|
19.5%
39/200 • Up to 16 months
mITT population was analyzed for safety data.
|
19.5%
38/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Vomiting
|
13.0%
26/200 • Up to 16 months
mITT population was analyzed for safety data.
|
11.3%
22/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
12/200 • Up to 16 months
mITT population was analyzed for safety data.
|
5.6%
11/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Gastrointestinal disorders
Stomatitis
|
6.0%
12/200 • Up to 16 months
mITT population was analyzed for safety data.
|
4.1%
8/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.0%
46/200 • Up to 16 months
mITT population was analyzed for safety data.
|
18.5%
36/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.5%
31/200 • Up to 16 months
mITT population was analyzed for safety data.
|
14.9%
29/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.5%
15/200 • Up to 16 months
mITT population was analyzed for safety data.
|
4.1%
8/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
10/200 • Up to 16 months
mITT population was analyzed for safety data.
|
4.6%
9/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.5%
11/200 • Up to 16 months
mITT population was analyzed for safety data.
|
2.1%
4/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Nervous system disorders
Headache
|
12.0%
24/200 • Up to 16 months
mITT population was analyzed for safety data.
|
10.3%
20/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Nervous system disorders
Dysgeusia
|
6.5%
13/200 • Up to 16 months
mITT population was analyzed for safety data.
|
10.3%
20/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Nervous system disorders
Dizziness
|
10.5%
21/200 • Up to 16 months
mITT population was analyzed for safety data.
|
5.1%
10/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.0%
12/200 • Up to 16 months
mITT population was analyzed for safety data.
|
3.6%
7/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Nervous system disorders
Neuropathy peripheral
|
4.0%
8/200 • Up to 16 months
mITT population was analyzed for safety data.
|
5.1%
10/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Blood and lymphatic system disorders
Anaemia
|
22.0%
44/200 • Up to 16 months
mITT population was analyzed for safety data.
|
10.8%
21/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.0%
34/200 • Up to 16 months
mITT population was analyzed for safety data.
|
4.6%
9/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.0%
22/200 • Up to 16 months
mITT population was analyzed for safety data.
|
1.0%
2/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.5%
33/200 • Up to 16 months
mITT population was analyzed for safety data.
|
19.0%
37/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.5%
17/200 • Up to 16 months
mITT population was analyzed for safety data.
|
4.1%
8/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
10/200 • Up to 16 months
mITT population was analyzed for safety data.
|
5.6%
11/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.0%
36/200 • Up to 16 months
mITT population was analyzed for safety data.
|
17.9%
35/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
10/200 • Up to 16 months
mITT population was analyzed for safety data.
|
9.2%
18/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
2.0%
4/200 • Up to 16 months
mITT population was analyzed for safety data.
|
6.7%
13/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
8/200 • Up to 16 months
mITT population was analyzed for safety data.
|
10.3%
20/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
11/200 • Up to 16 months
mITT population was analyzed for safety data.
|
8.7%
17/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.5%
7/200 • Up to 16 months
mITT population was analyzed for safety data.
|
7.7%
15/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.5%
7/200 • Up to 16 months
mITT population was analyzed for safety data.
|
7.2%
14/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.5%
11/200 • Up to 16 months
mITT population was analyzed for safety data.
|
3.1%
6/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.0%
6/200 • Up to 16 months
mITT population was analyzed for safety data.
|
5.1%
10/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Psychiatric disorders
Insomnia
|
9.5%
19/200 • Up to 16 months
mITT population was analyzed for safety data.
|
14.4%
28/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Psychiatric disorders
Anxiety
|
5.5%
11/200 • Up to 16 months
mITT population was analyzed for safety data.
|
5.6%
11/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Psychiatric disorders
Confusional state
|
5.0%
10/200 • Up to 16 months
mITT population was analyzed for safety data.
|
1.5%
3/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Eye disorders
Lacrimation increased
|
2.5%
5/200 • Up to 16 months
mITT population was analyzed for safety data.
|
6.7%
13/195 • Up to 16 months
mITT population was analyzed for safety data.
|
|
Vascular disorders
Hypotension
|
5.0%
10/200 • Up to 16 months
mITT population was analyzed for safety data.
|
3.6%
7/195 • Up to 16 months
mITT population was analyzed for safety data.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER