A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00191451
Collaborator
(none)
150
1
3
54
2.8
Study Details
Study Description
Brief Summary
The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
150 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial of Gemzar Plus Paraplatin (Plus Herceptin in HER2+ Patients) in Metastatic Breast Cancer
Study Start Date
:
Apr 1, 2004
Actual Primary Completion Date
:
Oct 1, 2008
Actual Study Completion Date
:
Oct 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HER2+ Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin. |
Drug: Gemcitabine
Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion)
Other Names:
Drug: Carboplatin
Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).
Other Names:
Drug: Herceptin
Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion).
Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion).
|
| Experimental: HER2- (Taxane-) Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients). |
Drug: Gemcitabine
Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion)
Other Names:
Drug: Carboplatin
Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).
Other Names:
|
| Experimental: HER2- (Taxane+) Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients). |
Drug: Gemcitabine
Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion)
Other Names:
Drug: Carboplatin
Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Tumor Response [baseline to disease progression/recurrence (up to 3.5 years)]
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Secondary Outcome Measures
- Duration of Response [date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years)]
Among tumor responders, the duration of tumor response is measured from the date of response (complete response [CR] or partial response [PR]) until the first date of documented progression or death from any cause. Duration of tumor response will be censored at the date of the last follow-up visit for tumor responders who are still alive and who have not progressed.
- Number of Patients Who Experienced Alopecia [Baseline to 3.5 years]
- Time to Disease Progression (TTP) [randomization date to the earliest date of the first documented disease progression date or the date of death if the patient dies due to study disease (up to 3.5 years)]
If a patient is lost to follow-up, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient died due to reason other than study disease, and patient has not progressed or received any new treatment, TTP is censored at the date of death.
- Percentage of Patients With Overall Survival at 1 Year and 2 Years [1 Year, 2 Years]
Kaplan-Meier estimates of overall survival (percentage of patients surviving) at 1 year and 2 years.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of metastatic breast cancer
-
Able to visit the doctor's office at least every 14 days during the actual treatment
-
Able to care for yourself, even if you cannot work or participate in other normal activities
-
Your blood results must be adequate for therapy.
-
If you are a female of childbearing potential and test negative for pregnancy, use a reliable method of birth control during and for three months following the last dose of study drug.
Exclusion Criteria:
-
Have received gemcitabine, paraplatin, or trastuzumab for your cancer.
-
Be pregnant or breastfeeding
-
Have cancer to the brain and has not been treated
-
Have another active cancer besides breast cancer
-
Have received stem cell or bone marrow transplant for hematologic (blood type) cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Indianapolis | Indiana | United States | 46203 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00191451
Other Study ID Numbers:
- 9397
- B9E-US-S359
First Posted:
Sep 19, 2005
Last Update Posted:
Nov 20, 2009
Last Verified:
Nov 1, 2009
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | HER2+ | HER2- (Taxane-) | HER2- (Taxane+) |
|---|---|---|---|
| Arm/Group Description | Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin. Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
| Period Title: Overall Study | |||
| STARTED | 50 | 51 | 49 |
| Received at Least One Dose of Study Drug | 50 | 48 | 47 |
| COMPLETED | 43 | 37 | 35 |
| NOT COMPLETED | 7 | 14 | 14 |
Baseline Characteristics
| Arm/Group Title | HER2+ | HER2- (Taxane-) | HER2- (Taxane+) | Total |
|---|---|---|---|---|
| Arm/Group Description | Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin. Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). | Total of all reporting groups |
| Overall Participants | 50 | 51 | 49 | 150 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
56.1
(9.45)
|
55.7
(11.17)
|
54.8
(9.92)
|
55.55
(10.16)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
50
100%
|
51
100%
|
49
100%
|
150
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
50
100%
|
51
100%
|
49
100%
|
150
100%
|
| Eastern Cooperative Oncology Group Performance Status (participants) [Number] | ||||
| 0 - Fully Active |
41
82%
|
36
70.6%
|
32
65.3%
|
109
72.7%
|
| 1 - Ambulatory, Restricted Strenuous Activity |
8
16%
|
14
27.5%
|
17
34.7%
|
39
26%
|
| 2 - Ambulatory, No Work Activities |
1
2%
|
1
2%
|
0
0%
|
2
1.3%
|
| Race/Ethnicity (participants) [Number] | ||||
| Caucasian |
31
62%
|
42
82.4%
|
36
73.5%
|
109
72.7%
|
| Black |
8
16%
|
5
9.8%
|
11
22.4%
|
24
16%
|
| Hispanic |
7
14%
|
4
7.8%
|
1
2%
|
12
8%
|
| Other |
4
8%
|
0
0%
|
1
2%
|
5
3.3%
|
Outcome Measures
| Title | Overall Tumor Response |
|---|---|
| Description | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. |
| Time Frame | baseline to disease progression/recurrence (up to 3.5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy evaluable subjects include all subjects who received at least 2 cycles of treatment with at least 1 follow-up tumor assessment, and did not violate the protocol in any fundamental manner related to the evaluation of efficacy. |
| Arm/Group Title | HER2+ | HER2- (Taxane-) | HER2- (Taxane+) |
|---|---|---|---|
| Arm/Group Description | Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin. Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
| Measure Participants | 50 | 47 | 47 |
| Complete Response (CR) |
6
12%
|
0
0%
|
1
2%
|
| Partial Response (PR) |
26
52%
|
13
25.5%
|
15
30.6%
|
| Stable Disease (SD) |
12
24%
|
20
39.2%
|
13
26.5%
|
| Progressive Disease (PD) |
4
8%
|
12
23.5%
|
17
34.7%
|
| Not Evaluable (NE) |
2
4%
|
2
3.9%
|
1
2%
|
| Title | Duration of Response |
|---|---|
| Description | Among tumor responders, the duration of tumor response is measured from the date of response (complete response [CR] or partial response [PR]) until the first date of documented progression or death from any cause. Duration of tumor response will be censored at the date of the last follow-up visit for tumor responders who are still alive and who have not progressed. |
| Time Frame | date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of patients with complete or partial response. Censored patients: 6 in HER2+, 6 in HER2- (Taxane-), and 5 in HER2- (Taxane+). |
| Arm/Group Title | HER2+ | HER2- (Taxane-) | HER2- (Taxane+) |
|---|---|---|---|
| Arm/Group Description | Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin. Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
| Measure Participants | 32 | 13 | 16 |
| Median (Full Range) [months] |
6.9
|
6.4
|
5.6
|
| Title | Number of Patients Who Experienced Alopecia |
|---|---|
| Description | |
| Time Frame | Baseline to 3.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of patients who received at least one dose of study drug. |
| Arm/Group Title | HER2+ | HER2- (Taxane-) | HER2- (Taxane+) |
|---|---|---|---|
| Arm/Group Description | Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin. Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
| Measure Participants | 50 | 48 | 47 |
| Number [participants] |
21
42%
|
17
33.3%
|
16
32.7%
|
| Title | Time to Disease Progression (TTP) |
|---|---|
| Description | If a patient is lost to follow-up, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient died due to reason other than study disease, and patient has not progressed or received any new treatment, TTP is censored at the date of death. |
| Time Frame | randomization date to the earliest date of the first documented disease progression date or the date of death if the patient dies due to study disease (up to 3.5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat population: all randomized patients. Censored patients: 10 in HER2+, 20 in HER2- (Taxane-), and 12 in HER2- (Taxane+). |
| Arm/Group Title | HER2+ | HER2- (Taxane-) | HER2- (Taxane+) |
|---|---|---|---|
| Arm/Group Description | Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin. Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
| Measure Participants | 50 | 51 | 49 |
| Median (95% Confidence Interval) [months] |
7.2
|
5.6
|
4.6
|
| Title | Percentage of Patients With Overall Survival at 1 Year and 2 Years |
|---|---|
| Description | Kaplan-Meier estimates of overall survival (percentage of patients surviving) at 1 year and 2 years. |
| Time Frame | 1 Year, 2 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat population: all randomized patients. Censored patients: 31 HER2+; 19 HER2- (Taxane-); 9 HER2- (Taxane+). |
| Arm/Group Title | HER2+ | HER2- (Taxane-) | HER2- (Taxane+) |
|---|---|---|---|
| Arm/Group Description | Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin. Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). |
| Measure Participants | 50 | 51 | 49 |
| 1 Year Overall Survival |
90.0
180%
|
67.5
132.4%
|
47.8
97.6%
|
| 2 Year Overall Survival |
73.3
146.6%
|
41.4
81.2%
|
20.5
41.8%
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events are provided for all patients who received at least one dose of study drug. Adverse events represent all grades (I-IV). | |||||
| Arm/Group Title | HER2+ | HER2- (Taxane-) | HER2- (Taxane+) | |||
| Arm/Group Description | Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin. Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). | Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients). Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). | |||
All Cause Mortality |
||||||
| HER2+ | HER2- (Taxane-) | HER2- (Taxane+) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| HER2+ | HER2- (Taxane-) | HER2- (Taxane+) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/50 (20%) | 11/48 (22.9%) | 10/47 (21.3%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/50 (0%) | 0 | 4/48 (8.3%) | 4 | 2/47 (4.3%) | 2 |
| Febrile neutropenia | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Neutropenia | 0/50 (0%) | 0 | 2/48 (4.2%) | 2 | 1/47 (2.1%) | 1 |
| Thrombocytopenia | 0/50 (0%) | 0 | 2/48 (4.2%) | 2 | 0/47 (0%) | 0 |
| Cardiac disorders | ||||||
| Diastolic dysfunction | 0/50 (0%) | 0 | 1/48 (2.1%) | 1 | 0/47 (0%) | 0 |
| Tachycardia | 0/50 (0%) | 0 | 1/48 (2.1%) | 1 | 0/47 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Intestinal obstruction | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Nausea | 1/50 (2%) | 1 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Oesophageal spasm | 0/50 (0%) | 0 | 1/48 (2.1%) | 1 | 0/47 (0%) | 0 |
| Oesophagitis | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Retching | 0/50 (0%) | 0 | 1/48 (2.1%) | 1 | 0/47 (0%) | 0 |
| Upper gastrointestinal haemorrhage | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Vomiting | 1/50 (2%) | 1 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| General disorders | ||||||
| Chest discomfort | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Chest pain | 0/50 (0%) | 0 | 1/48 (2.1%) | 1 | 1/47 (2.1%) | 1 |
| Disease progression | 1/50 (2%) | 1 | 0/48 (0%) | 0 | 0/47 (0%) | 0 |
| Localised oedema | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Mucous membrane disorder | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Multi-organ failure | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Oedema peripheral | 0/50 (0%) | 0 | 1/48 (2.1%) | 1 | 0/47 (0%) | 0 |
| Pain | 1/50 (2%) | 1 | 0/48 (0%) | 0 | 0/47 (0%) | 0 |
| Pyrexia | 0/50 (0%) | 0 | 2/48 (4.2%) | 2 | 0/47 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| Hyperbilirubinaemia | 0/50 (0%) | 0 | 1/48 (2.1%) | 1 | 0/47 (0%) | 0 |
| Jaundice | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Immune system disorders | ||||||
| Hypersensitivity | 0/50 (0%) | 0 | 1/48 (2.1%) | 1 | 0/47 (0%) | 0 |
| Infections and infestations | ||||||
| Catheter sepsis | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Fungaemia | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Pneumonia | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Sepsis | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 2 |
| Wound infection | 0/50 (0%) | 0 | 1/48 (2.1%) | 1 | 0/47 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Dehydration | 1/50 (2%) | 1 | 0/48 (0%) | 0 | 1/47 (2.1%) | 2 |
| Hypoglycaemia | 0/50 (0%) | 0 | 1/48 (2.1%) | 1 | 0/47 (0%) | 0 |
| Hypovolaemia | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Malnutrition | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 1/50 (2%) | 1 | 0/48 (0%) | 0 | 0/47 (0%) | 0 |
| Muscular weakness | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Musculoskeletal chest pain | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Breast cancer metastatic | 1/50 (2%) | 1 | 0/48 (0%) | 0 | 0/47 (0%) | 0 |
| Nervous system disorders | ||||||
| Dizziness | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Headache | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Intracranial hypotension | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Neurological symptom | 1/50 (2%) | 1 | 0/48 (0%) | 0 | 0/47 (0%) | 0 |
| Somnolence | 1/50 (2%) | 1 | 0/48 (0%) | 0 | 0/47 (0%) | 0 |
| Spinal cord compression | 0/50 (0%) | 0 | 1/48 (2.1%) | 1 | 0/47 (0%) | 0 |
| Syncope | 1/50 (2%) | 1 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea | 1/50 (2%) | 2 | 4/48 (8.3%) | 5 | 2/47 (4.3%) | 2 |
| Haemothorax | 1/50 (2%) | 1 | 0/48 (0%) | 0 | 0/47 (0%) | 0 |
| Hypoxia | 0/50 (0%) | 0 | 1/48 (2.1%) | 2 | 1/47 (2.1%) | 1 |
| Lung infiltration | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Orthopnoea | 0/50 (0%) | 0 | 1/48 (2.1%) | 1 | 0/47 (0%) | 0 |
| Pleural effusion | 1/50 (2%) | 1 | 1/48 (2.1%) | 1 | 0/47 (0%) | 0 |
| Pneumonia aspiration | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Vascular disorders | ||||||
| Vena cava thrombosis | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| HER2+ | HER2- (Taxane-) | HER2- (Taxane+) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 50/50 (100%) | 48/48 (100%) | 45/47 (95.7%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 31/50 (62%) | 60 | 24/48 (50%) | 35 | 22/47 (46.8%) | 35 |
| Leukopenia | 16/50 (32%) | 47 | 20/48 (41.7%) | 64 | 10/47 (21.3%) | 29 |
| Lymphopenia | 4/50 (8%) | 11 | 2/48 (4.2%) | 2 | 0/47 (0%) | 0 |
| Neutropenia | 35/50 (70%) | 102 | 37/48 (77.1%) | 109 | 28/47 (59.6%) | 77 |
| Thrombocytopenia | 13/50 (26%) | 34 | 17/48 (35.4%) | 47 | 15/47 (31.9%) | 32 |
| Cardiac disorders | ||||||
| Tachycardia | 0/50 (0%) | 0 | 3/48 (6.3%) | 3 | 3/47 (6.4%) | 3 |
| Ear and labyrinth disorders | ||||||
| Vertigo | 1/50 (2%) | 1 | 5/48 (10.4%) | 7 | 0/47 (0%) | 0 |
| Eye disorders | ||||||
| Lacrimation increased | 3/50 (6%) | 3 | 2/48 (4.2%) | 2 | 1/47 (2.1%) | 1 |
| Vision blurred | 1/50 (2%) | 1 | 3/48 (6.3%) | 3 | 1/47 (2.1%) | 1 |
| Gastrointestinal disorders | ||||||
| Abdominal pain upper | 2/50 (4%) | 2 | 3/48 (6.3%) | 3 | 2/47 (4.3%) | 2 |
| Constipation | 19/50 (38%) | 27 | 19/48 (39.6%) | 30 | 14/47 (29.8%) | 18 |
| Diarrhoea | 10/50 (20%) | 17 | 13/48 (27.1%) | 20 | 8/47 (17%) | 9 |
| Haemorrhoids | 4/50 (8%) | 4 | 1/48 (2.1%) | 1 | 2/47 (4.3%) | 2 |
| Nausea | 27/50 (54%) | 59 | 33/48 (68.8%) | 71 | 22/47 (46.8%) | 44 |
| Stomatitis | 7/50 (14%) | 8 | 6/48 (12.5%) | 6 | 2/47 (4.3%) | 2 |
| Vomiting | 13/50 (26%) | 17 | 18/48 (37.5%) | 32 | 12/47 (25.5%) | 21 |
| General disorders | ||||||
| Asthenia | 1/50 (2%) | 1 | 6/48 (12.5%) | 8 | 3/47 (6.4%) | 4 |
| Chest discomfort | 3/50 (6%) | 3 | 0/48 (0%) | 0 | 0/47 (0%) | 0 |
| Chest pain | 4/50 (8%) | 5 | 5/48 (10.4%) | 5 | 6/47 (12.8%) | 6 |
| Chills | 4/50 (8%) | 5 | 7/48 (14.6%) | 9 | 5/47 (10.6%) | 6 |
| Fatigue | 37/50 (74%) | 70 | 35/48 (72.9%) | 56 | 30/47 (63.8%) | 50 |
| Mucosal inflammation | 1/50 (2%) | 2 | 3/48 (6.3%) | 4 | 4/47 (8.5%) | 4 |
| Oedema | 4/50 (8%) | 5 | 5/48 (10.4%) | 5 | 2/47 (4.3%) | 2 |
| Oedema peripheral | 5/50 (10%) | 7 | 6/48 (12.5%) | 8 | 10/47 (21.3%) | 11 |
| Pain | 3/50 (6%) | 3 | 2/48 (4.2%) | 2 | 6/47 (12.8%) | 6 |
| Pyrexia | 6/50 (12%) | 7 | 4/48 (8.3%) | 5 | 5/47 (10.6%) | 8 |
| Infections and infestations | ||||||
| Rhinitis | 6/50 (12%) | 6 | 2/48 (4.2%) | 2 | 0/47 (0%) | 0 |
| Upper respiratory tract infection | 5/50 (10%) | 6 | 4/48 (8.3%) | 4 | 3/47 (6.4%) | 3 |
| Urinary tract infection | 2/50 (4%) | 2 | 4/48 (8.3%) | 4 | 2/47 (4.3%) | 2 |
| Injury, poisoning and procedural complications | ||||||
| Contusion | 1/50 (2%) | 2 | 1/48 (2.1%) | 1 | 3/47 (6.4%) | 3 |
| Investigations | ||||||
| Alanine aminotransferase | 6/50 (12%) | 8 | 7/48 (14.6%) | 7 | 1/47 (2.1%) | 2 |
| Alanine aminotransferase increased | 10/50 (20%) | 16 | 10/48 (20.8%) | 14 | 7/47 (14.9%) | 8 |
| Aspartate aminotransferase | 4/50 (8%) | 5 | 5/48 (10.4%) | 6 | 1/47 (2.1%) | 1 |
| Aspartate aminotransferase increased | 10/50 (20%) | 16 | 12/48 (25%) | 16 | 5/47 (10.6%) | 7 |
| Blood alkaline phosphatase | 3/50 (6%) | 3 | 0/48 (0%) | 0 | 1/47 (2.1%) | 2 |
| Blood alkaline phosphatase increased | 8/50 (16%) | 10 | 5/48 (10.4%) | 5 | 5/47 (10.6%) | 6 |
| Blood calcium decreased | 2/50 (4%) | 2 | 3/48 (6.3%) | 3 | 1/47 (2.1%) | 3 |
| Blood glucose increased | 2/50 (4%) | 4 | 3/48 (6.3%) | 5 | 2/47 (4.3%) | 2 |
| Blood lactate dehydrogenase increased | 3/50 (6%) | 3 | 1/48 (2.1%) | 1 | 0/47 (0%) | 0 |
| Haemoglobin | 11/50 (22%) | 11 | 9/48 (18.8%) | 10 | 7/47 (14.9%) | 9 |
| Haemoglobin decreased | 2/50 (4%) | 6 | 7/48 (14.6%) | 11 | 2/47 (4.3%) | 3 |
| Neutrophil count | 5/50 (10%) | 10 | 2/48 (4.2%) | 2 | 1/47 (2.1%) | 3 |
| Platelet count | 4/50 (8%) | 11 | 8/48 (16.7%) | 16 | 7/47 (14.9%) | 12 |
| Platelet count increased | 3/50 (6%) | 3 | 0/48 (0%) | 0 | 0/47 (0%) | 0 |
| White blood cell count | 6/50 (12%) | 15 | 5/48 (10.4%) | 10 | 8/47 (17%) | 15 |
| White blood cell count decreased | 3/50 (6%) | 9 | 2/48 (4.2%) | 2 | 3/47 (6.4%) | 6 |
| Metabolism and nutrition disorders | ||||||
| Anorexia | 8/50 (16%) | 11 | 11/48 (22.9%) | 13 | 10/47 (21.3%) | 11 |
| Dehydration | 1/50 (2%) | 2 | 3/48 (6.3%) | 5 | 4/47 (8.5%) | 10 |
| Hyperglycaemia | 15/50 (30%) | 23 | 8/48 (16.7%) | 13 | 4/47 (8.5%) | 7 |
| Hypoalbuminaemia | 4/50 (8%) | 4 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Hypocalcaemia | 3/50 (6%) | 3 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Hypokalaemia | 5/50 (10%) | 7 | 4/48 (8.3%) | 6 | 1/47 (2.1%) | 2 |
| Hyponatraemia | 3/50 (6%) | 5 | 1/48 (2.1%) | 1 | 1/47 (2.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 9/50 (18%) | 12 | 9/48 (18.8%) | 16 | 5/47 (10.6%) | 5 |
| Back pain | 7/50 (14%) | 7 | 5/48 (10.4%) | 5 | 4/47 (8.5%) | 4 |
| Bone pain | 0/50 (0%) | 0 | 3/48 (6.3%) | 3 | 1/47 (2.1%) | 1 |
| Muscle spasms | 2/50 (4%) | 2 | 3/48 (6.3%) | 3 | 2/47 (4.3%) | 2 |
| Muscular weakness | 2/50 (4%) | 2 | 4/48 (8.3%) | 6 | 2/47 (4.3%) | 2 |
| Musculoskeletal chest pain | 3/50 (6%) | 3 | 2/48 (4.2%) | 2 | 5/47 (10.6%) | 7 |
| Musculoskeletal pain | 4/50 (8%) | 5 | 4/48 (8.3%) | 4 | 4/47 (8.5%) | 4 |
| Myalgia | 12/50 (24%) | 19 | 6/48 (12.5%) | 12 | 1/47 (2.1%) | 1 |
| Neck pain | 0/50 (0%) | 0 | 0/48 (0%) | 0 | 3/47 (6.4%) | 3 |
| Pain in extremity | 4/50 (8%) | 4 | 6/48 (12.5%) | 9 | 5/47 (10.6%) | 5 |
| Nervous system disorders | ||||||
| Dizziness | 4/50 (8%) | 6 | 10/48 (20.8%) | 15 | 4/47 (8.5%) | 4 |
| Dysgeusia | 5/50 (10%) | 10 | 7/48 (14.6%) | 9 | 3/47 (6.4%) | 3 |
| Hypoaesthesia | 1/50 (2%) | 1 | 1/48 (2.1%) | 1 | 4/47 (8.5%) | 4 |
| Neuropathy peripheral | 4/50 (8%) | 4 | 2/48 (4.2%) | 2 | 4/47 (8.5%) | 4 |
| Paraesthesia | 1/50 (2%) | 1 | 4/48 (8.3%) | 6 | 2/47 (4.3%) | 2 |
| Peripheral sensory neuropathy | 2/50 (4%) | 5 | 4/48 (8.3%) | 5 | 1/47 (2.1%) | 1 |
| Psychiatric disorders | ||||||
| Anxiety | 7/50 (14%) | 7 | 4/48 (8.3%) | 5 | 8/47 (17%) | 8 |
| Depression | 3/50 (6%) | 3 | 3/48 (6.3%) | 3 | 7/47 (14.9%) | 7 |
| Insomnia | 9/50 (18%) | 9 | 11/48 (22.9%) | 12 | 4/47 (8.5%) | 4 |
| Reproductive system and breast disorders | ||||||
| Breast pain | 3/50 (6%) | 3 | 2/48 (4.2%) | 4 | 0/47 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 16/50 (32%) | 24 | 11/48 (22.9%) | 14 | 10/47 (21.3%) | 13 |
| Dyspnoea | 11/50 (22%) | 14 | 7/48 (14.6%) | 10 | 11/47 (23.4%) | 12 |
| Dyspnoea exertional | 1/50 (2%) | 1 | 3/48 (6.3%) | 3 | 0/47 (0%) | 0 |
| Nasal congestion | 5/50 (10%) | 6 | 0/48 (0%) | 0 | 1/47 (2.1%) | 1 |
| Paranasal sinus hypersecretion | 3/50 (6%) | 3 | 1/48 (2.1%) | 1 | 1/47 (2.1%) | 3 |
| Pharyngolaryngeal pain | 1/50 (2%) | 2 | 4/48 (8.3%) | 5 | 2/47 (4.3%) | 2 |
| Skin and subcutaneous tissue disorders | ||||||
| Alopecia | 21/50 (42%) | 22 | 17/48 (35.4%) | 22 | 16/47 (34%) | 16 |
| Dry skin | 2/50 (4%) | 2 | 0/48 (0%) | 0 | 3/47 (6.4%) | 3 |
| Erythema | 5/50 (10%) | 6 | 1/48 (2.1%) | 1 | 1/47 (2.1%) | 1 |
| Hyperhidrosis | 2/50 (4%) | 3 | 3/48 (6.3%) | 3 | 1/47 (2.1%) | 1 |
| Nail disorder | 3/50 (6%) | 3 | 1/48 (2.1%) | 1 | 1/47 (2.1%) | 1 |
| Night sweats | 2/50 (4%) | 2 | 2/48 (4.2%) | 2 | 3/47 (6.4%) | 3 |
| Pruritus | 6/50 (12%) | 7 | 3/48 (6.3%) | 5 | 4/47 (8.5%) | 5 |
| Rash | 11/50 (22%) | 14 | 7/48 (14.6%) | 9 | 5/47 (10.6%) | 5 |
| Vascular disorders | ||||||
| Hot flush | 4/50 (8%) | 5 | 7/48 (14.6%) | 8 | 4/47 (8.5%) | 4 |
| Lymphoedema | 1/50 (2%) | 1 | 3/48 (6.3%) | 3 | 3/47 (6.4%) | 3 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00191451
Other Study ID Numbers:
- 9397
- B9E-US-S359
First Posted:
Sep 19, 2005
Last Update Posted:
Nov 20, 2009
Last Verified:
Nov 1, 2009