Trial Outcomes & Findings for A Phase I/II Study of Oblimersen Plus Cisplatin and Fluorouracil in Gastric & Esophageal Junction Cancer (NCT NCT00064259)
NCT ID: NCT00064259
Last Updated: 2021-02-17
Results Overview
Adverse events were evaluated according to the National Cancer Institute Common Toxicity Criteria (version 2.0). DLT was defined as grade 3 to 4 hematologic toxicity lasting more than 1 week after 5-FU/cisplatin, grade 3 to 4 nausea or vomiting occurring later than 11 days after cisplatin, grade 3 to 4 diarrhea occurring later than 10 days after 5-FU, and grade 3 to 4 mucositis at the beginning of the next cycle.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
21 days
Results posted on
2021-02-17
Participant Flow
Participant milestones
| Measure |
Oblimersen 3 mg/kg/d +Cisplatin 100 mg/m2 +5-FU 1000 mg/m2
Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 1000 mg/m2/d on days 4 to 7 and cisplatin 100 mg/m2 on day 4.
|
Oblimersen 3 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2
Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
|
Oblimersen 5 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2
Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 5 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
|
Oblimersen 7 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2
Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 7 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
6
|
1
|
|
Overall Study
COMPLETED
|
3
|
4
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Oblimersen 3 mg/kg/d +Cisplatin 100 mg/m2 +5-FU 1000 mg/m2
Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 1000 mg/m2/d on days 4 to 7 and cisplatin 100 mg/m2 on day 4.
|
Oblimersen 3 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2
Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
|
Oblimersen 5 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2
Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 5 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
|
Oblimersen 7 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2
Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 7 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Phase I/II Study of Oblimersen Plus Cisplatin and Fluorouracil in Gastric & Esophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Oblimersen + Cisplatin + 5-FU
n=15 Participants
Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
|
|---|---|
|
Age, Continuous
|
55.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 daysAdverse events were evaluated according to the National Cancer Institute Common Toxicity Criteria (version 2.0). DLT was defined as grade 3 to 4 hematologic toxicity lasting more than 1 week after 5-FU/cisplatin, grade 3 to 4 nausea or vomiting occurring later than 11 days after cisplatin, grade 3 to 4 diarrhea occurring later than 10 days after 5-FU, and grade 3 to 4 mucositis at the beginning of the next cycle.
Outcome measures
| Measure |
Oblimersen + Cisplatin + 5-FU
n=15 Participants
Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Oblimersen in Combination With Cisplatin and 5-FU
|
5 mg/kg/d
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Outcome was not analysed. No patients had samples obtained for microarray analysis.
This will be primarily descriptive, and will seek to compare patterns of gene expression pre- and post-treatment.
Outcome measures
Outcome data not reported
Adverse Events
Oblimersen + Cisplatin + 5-FU
Serious events: 8 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oblimersen + Cisplatin + 5-FU
n=15 participants at risk
Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
5/15
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
1/15
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
1/15
|
|
Infections and infestations
Infection
|
20.0%
3/15
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15
|
|
Hepatobiliary disorders
Transaminase elevation
|
6.7%
1/15
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
6.7%
1/15
|
|
Renal and urinary disorders
Creatinine
|
6.7%
1/15
|
|
Renal and urinary disorders
Ureteral obstruction
|
6.7%
1/15
|
|
General disorders
Fatigue
|
13.3%
2/15
|
|
General disorders
Dizziness
|
13.3%
2/15
|
|
Vascular disorders
Vascular/Thrombosis
|
13.3%
2/15
|
|
Metabolism and nutrition disorders
Hypokalemia
|
26.7%
4/15
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
1/15
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
2/15
|
|
Nervous system disorders
Sensory neuropathy
|
6.7%
1/15
|
|
Nervous system disorders
Motor neuropathy
|
6.7%
1/15
|
|
General disorders
Pleural effusion
|
6.7%
1/15
|
|
General disorders
Ascites
|
6.7%
1/15
|
Other adverse events
| Measure |
Oblimersen + Cisplatin + 5-FU
n=15 participants at risk
Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
3/15
|
|
Blood and lymphatic system disorders
Anemia
|
53.3%
8/15
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.3%
2/15
|
|
Gastrointestinal disorders
Mucositis
|
26.7%
4/15
|
|
Gastrointestinal disorders
Nausea
|
26.7%
4/15
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
13.3%
2/15
|
|
General disorders
Weight loss
|
13.3%
2/15
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15
|
|
General disorders
Fatigue
|
20.0%
3/15
|
|
General disorders
Dizziness
|
6.7%
1/15
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
1/15
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15
|
|
General disorders
Peripheral edema
|
13.3%
2/15
|
Additional Information
NYCC Regulatory Coordinator
Montefiore Medical Center - New York
Phone: 718-405-8404
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60