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A Phase I/II Study of Oblimersen Plus Cisplatin and Fluorouracil in Gastric & Esophageal Junction Cancer

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ClinicalTrials.gov Identifier: NCT00064259
Recruitment Status : Terminated (Discontinued development of G3139 (oblimersen))
First Posted : July 9, 2003
Results First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Esophagus
Adenocarcinoma of the Gastroesophageal Junction
Diffuse Adenocarcinoma of the Stomach
Intestinal Adenocarcinoma of the Stomach
Mixed Adenocarcinoma of the Stomach
Recurrent Esophageal Cancer
Recurrent Gastric Cancer
Squamous Cell Carcinoma of the Esophagus
Stage III Esophageal Cancer
Stage IIIA Gastric Cancer
Stage IIIB Gastric Cancer
Stage IIIC Gastric Cancer
Stage IV Esophageal Cancer
Stage IV Gastric Cancer
Interventions Biological: oblimersen sodium
Drug: cisplatin
Drug: fluorouracil
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oblimersen 3 mg/kg/d +Cisplatin 100 mg/m2 +5-FU 1000 mg/m2 Oblimersen 3 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2 Oblimersen 5 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2 Oblimersen 7 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 4 4 6 1
Completed 3 4 6 0
Not Completed 1 0 0 1
Reason Not Completed
Adverse Event             1             0             0             1
Arm/Group Title Oblimersen + Cisplatin + 5-FU
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
Total number of participants at different dose levels of Oblimersen (3, 5, or 7 mg/kg/d) in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) and Cisplatin (100 mg/m2 or 75 mg/m2)
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
55.0
(36 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
6
  40.0%
Male
9
  60.0%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Oblimersen in Combination With Cisplatin and 5-FU
Hide Description 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.
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oblimersen + Cisplatin + 5-FU
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: mg/kg/d
5
2.Secondary Outcome
Title Microarray Data
Hide Description This will be primarily descriptive, and will seek to compare patterns of gene expression pre- and post-treatment.
Time Frame Up to 12 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oblimersen + Cisplatin + 5-FU
Hide Arm/Group Description 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.
All-Cause Mortality
Oblimersen + Cisplatin + 5-FU
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oblimersen + Cisplatin + 5-FU
Affected / at Risk (%)
Total   8/15 (53.33%) 
Blood and lymphatic system disorders   
Neutropenia  1  5/15 (33.33%) 
Anemia  1  1/15 (6.67%) 
Thrombocytopenia  1  1/15 (6.67%) 
Gastrointestinal disorders   
Vomiting  1  1/15 (6.67%) 
Dysphagia  1  1/15 (6.67%) 
General disorders   
Fatigue  1  2/15 (13.33%) 
Dizziness  1  2/15 (13.33%) 
Pleural effusion  1  1/15 (6.67%) 
Ascites  1  1/15 (6.67%) 
Hepatobiliary disorders   
Transaminase elevation  1  1/15 (6.67%) 
Alkaline phosphatase  1  1/15 (6.67%) 
Infections and infestations   
Infection  1  3/15 (20.00%) 
Metabolism and nutrition disorders   
Hypokalemia  1  4/15 (26.67%) 
Hyponatremia  1  1/15 (6.67%) 
Dehydration  1  2/15 (13.33%) 
Nervous system disorders   
Sensory neuropathy  1  1/15 (6.67%) 
Motor neuropathy  1  1/15 (6.67%) 
Renal and urinary disorders   
Creatinine  1  1/15 (6.67%) 
Ureteral obstruction  1  1/15 (6.67%) 
Vascular disorders   
Vascular/Thrombosis  1  2/15 (13.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oblimersen + Cisplatin + 5-FU
Affected / at Risk (%)
Total   9/15 (60.00%) 
Blood and lymphatic system disorders   
Neutropenia  1  3/15 (20.00%) 
Anemia  1  8/15 (53.33%) 
Thrombocytopenia  1  2/15 (13.33%) 
Gastrointestinal disorders   
Mucositis  1  4/15 (26.67%) 
Nausea  1  4/15 (26.67%) 
Vomiting  1  2/15 (13.33%) 
Diarrhea  1  2/15 (13.33%) 
General disorders   
Weight loss  1  2/15 (13.33%) 
Fatigue  1  3/15 (20.00%) 
Dizziness  1  1/15 (6.67%) 
Peripheral edema  1  2/15 (13.33%) 
Hepatobiliary disorders   
Alkaline phosphatase  1  2/15 (13.33%) 
Metabolism and nutrition disorders   
Anorexia  1  1/15 (6.67%) 
Hyperglycemia  1  1/15 (6.67%) 
Hypomagnesaemia  1  1/15 (6.67%) 
Dehydration  1  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: NYCC Regulatory Coordinator
Organization: Montefiore Medical Center - New York
Phone: 718-379-6862
EMail: sforde@montefiore.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00064259     History of Changes
Other Study ID Numbers: NCI-2012-03134
02-66 ( Other Identifier: Montefiore Medical Center )
N01CM62204 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2003
First Posted: July 9, 2003
Results First Submitted: June 10, 2015
Results First Posted: June 29, 2015
Last Update Posted: June 29, 2015