Trial Outcomes & Findings for Phase II Study Using CHFR Methylation Status in Patients With Metastatic Esophageal, Gastroesophageal, Gastric Cancer. (NCT NCT01715233)

Last Updated: 2019-03-15

Results Overview

Number of participants treated with mDCF with progressive disease (PD), stable disease (SD), partial response (PR), non-complete response and non-progressive disease (non-CR/non-PD), and partial response with progressive disease clinically (PR/PD) as defined by RECIST criteria. Response is compared based on CHFR-methylation status.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

4 months

Results posted on

2019-03-15

Participant Flow

6 subjects were screen failures.

Participant milestones

Participant milestones
Measure	Metastatic Esophageal, Gastroesophageal & Gastric Cancer Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer. Docetaxel: Modified Docetaxel 40mg/m2 on Day 1 Leucovorin: Leucovorin 400mg/m2 on Day 1 Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study Using CHFR Methylation Status in Patients With Metastatic Esophageal, Gastroesophageal, Gastric Cancer.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metastatic Esophageal, Gastroesophageal & Gastric Cancer n=21 Participants Participants receive modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer. Docetaxel: Modified Docetaxel 40mg/m2 on Day 1 Leucovorin: Leucovorin 400mg/m2 on Day 1 Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3
Age, Continuous	66 years STANDARD_DEVIATION 9.70 • n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	15 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Race (NIH/OMB) White	18 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	21 Participants n=99 Participants

PRIMARY outcome

Timeframe: 4 months

Population: Response could not be assessed in 2/21 participants since imaging was not evaluable, therefore RECIST reads could not be obtained.

Outcome measures

Outcome measures
Measure	Metastatic Esophageal, Gastroesophageal & Gastric Cancer. n=19 Participants Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer. Docetaxel: Modified Docetaxel 40mg/m2 on Day 1 Leucovorin: Leucovorin 400mg/m2 on Day 1 Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3
Response Unknown methylation status · PD	0 Participants
Response CHFR-methylated · PD	3 Participants
Response CHFR-methylated · SD	0 Participants
Response CHFR-methylated · PR	2 Participants
Response CHFR-methylated · non-CR/non-PD	0 Participants
Response CHFR-methylated · PR/PD	1 Participants
Response CHFR-unmethylated · PD	3 Participants
Response CHFR-unmethylated · SD	3 Participants
Response CHFR-unmethylated · PR	5 Participants
Response CHFR-unmethylated · non-CR/non-PD	1 Participants
Response CHFR-unmethylated · PR/PD	0 Participants
Response Unknown methylation status · SD	0 Participants
Response Unknown methylation status · PR	1 Participants
Response Unknown methylation status · non-CR/non-PD	0 Participants
Response Unknown methylation status · PR/PD	0 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Only 18/21 participants had evaluable data for this outcome measure.

Number of participants with advanced esophagogastric cancer that are CHFR-methylated or unmethylated at baseline.

Outcome measures

Outcome measures
Measure	Metastatic Esophageal, Gastroesophageal & Gastric Cancer. n=18 Participants Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer. Docetaxel: Modified Docetaxel 40mg/m2 on Day 1 Leucovorin: Leucovorin 400mg/m2 on Day 1 Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3
CHFR Methylation Status CHFR-methylated	6 Participants
CHFR Methylation Status CHFR-unmethylated	12 Participants

SECONDARY outcome

Timeframe: 2 Years

Number of participants alive at 2 years.

Outcome measures

Outcome measures
Measure	Metastatic Esophageal, Gastroesophageal & Gastric Cancer. n=21 Participants Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer. Docetaxel: Modified Docetaxel 40mg/m2 on Day 1 Leucovorin: Leucovorin 400mg/m2 on Day 1 Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3
Overall Survival	2 Participants

Adverse Events

Metastatic Esophageal, Gastroesophageal & Gastric Cancer

Serious events: 3 serious events

Other events: 18 other events

Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure	Metastatic Esophageal, Gastroesophageal & Gastric Cancer n=21 participants at risk Patients received modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer. Docetaxel: Modified Docetaxel 40mg/m2 on Day 1 Leucovorin: Leucovorin 400mg/m2 on Day 1 Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3
Blood and lymphatic system disorders Febrile Neutropenia	9.5% 2/21 • Number of events 2 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Renal and urinary disorders Urinary Retention	4.8% 1/21 • Number of events 1 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Respiratory, thoracic and mediastinal disorders Pneumonia	4.8% 1/21 • Number of events 1 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Blood and lymphatic system disorders Leukocytopenia	4.8% 1/21 • Number of events 3 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Blood and lymphatic system disorders Neutropenia	4.8% 1/21 • Number of events 1 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Gastrointestinal disorders Ileus	4.8% 1/21 • Number of events 1 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.

Other adverse events

Other adverse events
Measure	Metastatic Esophageal, Gastroesophageal & Gastric Cancer n=21 participants at risk Patients received modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer. Docetaxel: Modified Docetaxel 40mg/m2 on Day 1 Leucovorin: Leucovorin 400mg/m2 on Day 1 Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3
General disorders Hospitalization due to leg pain	4.8% 1/21 • Number of events 1 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Gastrointestinal disorders Diarrhea	9.5% 2/21 • Number of events 2 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Blood and lymphatic system disorders Anemia	4.8% 1/21 • Number of events 1 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Blood and lymphatic system disorders Leukocytopenia	23.8% 5/21 • Number of events 9 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Gastrointestinal disorders Dehydration	4.8% 1/21 • Number of events 1 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
General disorders Fainting	9.5% 2/21 • Number of events 2 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
General disorders Fatigue	4.8% 1/21 • Number of events 1 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Gastrointestinal disorders GI Bleed	4.8% 1/21 • Number of events 1 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Blood and lymphatic system disorders Hypomagnesemia	4.8% 1/21 • Number of events 1 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Cardiac disorders Hypotensive	4.8% 1/21 • Number of events 1 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Vascular disorders Increased INR	4.8% 1/21 • Number of events 1 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Blood and lymphatic system disorders Hypophosphatemia	14.3% 3/21 • Number of events 9 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Blood and lymphatic system disorders Lymphopenia	23.8% 5/21 • Number of events 7 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.
Blood and lymphatic system disorders Neutropenia	52.4% 11/21 • Number of events 16 • AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years. Only Grades 3 and 4 adverse events were collected for all patients.

Additional Information

Ronan J. Kelly MD MBA

Baylor University Medical Center Dallas Texas

Phone: 214-820-2828

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place