Trial Outcomes & Findings for Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma (NCT NCT00859469)
NCT ID: NCT00859469
Last Updated: 2019-10-30
Results Overview
Radiologic response by RECIST criteria will be compared between baseline and at 2 months. Disease assessment: Two objective status determinations of CR before progression are required for a best response of CR. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. Two determinations of stable/no response or better before progression, but not qualifying as CR or PR are required for a best response of stable/no response.
COMPLETED
PHASE2
29 participants
Two months
2019-10-30
Participant Flow
Patients will be screened using standard health care assessments and tests. All of these tests must be done within 4 weeks before patients begin treatment.
Patients who are deemed eligible will start the treatment cycle, defined as an interval of 14 days, and comprising of treatment with Gemcitabine followed immediately by Oxaliplatin.
Participant milestones
| Measure |
Oxaliplatin and Gemcitabine
The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
6 Cycles
|
16
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Oxaliplatin and Gemcitabine
The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
16
|
Baseline Characteristics
Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma
Baseline characteristics by cohort
| Measure |
Oxaliplatin and Gemcitabine
n=29 Participants
The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
|
Primary Site
Pleural
|
16 participants
n=5 Participants
|
|
Primary Site
Peritoneal
|
13 participants
n=5 Participants
|
|
Pathologic Subtype
Epithelioid
|
19 participants
n=5 Participants
|
|
Pathologic Subtype
Sarcomatoid
|
3 participants
n=5 Participants
|
|
Pathologic Subtype
Biphasic
|
7 participants
n=5 Participants
|
|
Prior chemotherapy regimens
0
|
11 participants
n=5 Participants
|
|
Prior chemotherapy regimens
1 or more
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two monthsPopulation: intention to treat principle
Radiologic response by RECIST criteria will be compared between baseline and at 2 months. Disease assessment: Two objective status determinations of CR before progression are required for a best response of CR. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. Two determinations of stable/no response or better before progression, but not qualifying as CR or PR are required for a best response of stable/no response.
Outcome measures
| Measure |
Oxaliplatin and Gemcitabine
n=29 Participants
The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
|
|---|---|
|
Best Response
Complete Response
|
0 participants
|
|
Best Response
Partial Response
|
7 participants
|
|
Best Response
Stable Disease
|
11 participants
|
|
Best Response
Progressive Disease
|
11 participants
|
SECONDARY outcome
Timeframe: 50 monthsPopulation: ITT
Outcome measures
| Measure |
Oxaliplatin and Gemcitabine
n=29 Participants
The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
|
|---|---|
|
Overall Survival
|
8 months
Interval 4.0 to 14.0
|
SECONDARY outcome
Timeframe: 50 monthsTime to radiologic disease progression or death
Outcome measures
| Measure |
Oxaliplatin and Gemcitabine
n=29 Participants
The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
|
|---|---|
|
Progression-free Survival
|
5 months
Interval 2.0 to 7.0
|
Adverse Events
Oxaliplatin and Gemcitabine
Serious adverse events
| Measure |
Oxaliplatin and Gemcitabine
n=28 participants at risk
The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.7%
3/28 • 50 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.6%
1/28 • 50 months
|
|
Hepatobiliary disorders
Elevated alkaline phosphatase
|
10.7%
3/28 • 50 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.6%
1/28 • 50 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.7%
3/28 • 50 months
|
|
Hepatobiliary disorders
Elevated AST
|
10.7%
3/28 • 50 months
|
|
Hepatobiliary disorders
Elevated ALT
|
10.7%
3/28 • 50 months
|
|
Hepatobiliary disorders
Elevated Bilirubin
|
3.6%
1/28 • 50 months
|
Other adverse events
| Measure |
Oxaliplatin and Gemcitabine
n=28 participants at risk
The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
|
|---|---|
|
Gastrointestinal disorders
Nausea/Vomiting
|
31.0%
9/29 • 50 months
|
|
Gastrointestinal disorders
Diarrhea
|
6.9%
2/29 • 50 months
|
|
Nervous system disorders
Peripheral neuropathy
|
37.9%
11/29 • 50 months
|
|
General disorders
Fever
|
6.9%
2/29 • 50 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.9%
2/29 • 50 months
|
|
Nervous system disorders
Vertigo
|
6.9%
2/29 • 50 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
4/28 • 50 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.2%
5/26 • 50 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
57.1%
16/28 • 50 months
|
|
Blood and lymphatic system disorders
Anemia
|
88.5%
23/26 • 50 months
|
|
Hepatobiliary disorders
Elevated alkaline phosphatase
|
57.7%
15/26 • 50 months
|
|
Hepatobiliary disorders
Elevated AST
|
50.0%
13/26 • 50 months
|
|
Hepatobiliary disorders
Elevated ALT
|
53.8%
14/26 • 50 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place