Trial Outcomes & Findings for Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients (NCT NCT00526110)

Last Updated: 2016-10-31

Results Overview

MTD is the highest dose at which 1 or fewer dose limiting toxicities (DLT's) are observed in 6 patients. DLT defined as any non-hematologic grade III/IV or neutropenia-associated (infection or fever treated in the hospital) toxicity attributable to this therapy. Response evaluated after two 14-day treatments of Docetaxel, 5-Fluorouracil and Oxaliplatin (One cycle = 28 days).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

98 participants

Primary outcome timeframe

28 days

Results posted on

2016-10-31

Participant Flow

Recruitment Period: September 8, 2004 to August 5, 2009. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Phase I: Dose Escalation Phase I: Starting dose of 20mg/m\^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m\^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m\^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m\^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).	Phase II: Docetaxel MTD 50 mg/m^2 Phase II: Docetaxel 50 mg/m\^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m\^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m\^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
Overall Study STARTED	53	45
Overall Study COMPLETED	51	4
Overall Study NOT COMPLETED	2	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I: Dose Escalation Phase I: Starting dose of 20mg/m\^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m\^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m\^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m\^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).	Phase II: Docetaxel MTD 50 mg/m^2 Phase II: Docetaxel 50 mg/m\^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m\^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m\^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
Overall Study Adverse Event	2	9
Overall Study Disease Progression	0	19
Overall Study Maximal Response	0	6
Overall Study Withdrawal by Subject	0	2
Overall Study Poor Tolerance	0	5

Baseline Characteristics

Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I n=53 Participants Phase I: Starting dose of 20mg/m\^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m\^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m\^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m\^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).	Phase II n=45 Participants Phase II: Docetaxel 50 mg/m\^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m\^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m\^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).	Total n=98 Participants Total of all reporting groups
Age, Continuous	55 years n=5 Participants	59 years n=7 Participants	57 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	31 Participants n=7 Participants	72 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants	45 participants n=7 Participants	98 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	Phase I n=53 Participants Phase I: Starting dose of 20mg/m\^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m\^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m\^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m\^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
Maximum Tolerated Dose (MTD)	50 mg/m^2

PRIMARY outcome

Timeframe: Assessed from baseline to 30 months

Progression Free Survival (PFS) defined as the time from the first study drug administration until the first day of radiological and/or symptomatic disease progression is documented, or the start of further anticancer therapy or death from any cause, whichever occurs first. Kaplan-Meier curve was used to estimate PFS. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion.

Outcome measures

Outcome measures
Measure	Phase I n=45 Participants Phase I: Starting dose of 20mg/m\^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m\^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m\^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m\^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
Progression Free Survival	6.5 months Interval 5.5 to 9.5

SECONDARY outcome

Timeframe: Up to 30 months

Overall survival was defined as the time from the start of treatment until death or last follow-up. Kaplan-Meier curve was used to estimate overall survival.

Outcome measures

Outcome measures
Measure	Phase I n=45 Participants Phase I: Starting dose of 20mg/m\^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m\^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m\^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m\^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
Median Overall Survival	11.1 months Interval 9.4 to 18.8

Adverse Events

Phase I

Serious events: 33 serious events

Other events: 53 other events

Deaths: 0 deaths

Phase II

Serious events: 13 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Jaffer Ajani, MD/Professor, GI Medical Oncology

The University of Texas (UT) MD Anderson Cancer Center

Phone: 1-877-632-6789

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase I n=53 participants at risk Phase I: Starting dose of 20mg/m\^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m\^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m\^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m\^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).	Phase II n=45 participants at risk Phase II: Docetaxel 50 mg/m\^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m\^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m\^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
Blood and lymphatic system disorders Leukopenia	3.8% 2/53 • Number of events 2 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	0.00% 0/45 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Blood and lymphatic system disorders Granulocytopenia	13.2% 7/53 • Number of events 7 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	0.00% 0/45 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Blood and lymphatic system disorders Anemia	7.5% 4/53 • Number of events 4 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	0.00% 0/45 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Metabolism and nutrition disorders Hypokalemia	1.9% 1/53 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	0.00% 0/45 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Metabolism and nutrition disorders Dehydration	1.9% 1/53 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	0.00% 0/45 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
General disorders Fatigue	20.8% 11/53 • Number of events 11 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	0.00% 0/45 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Gastrointestinal disorders Nausea	5.7% 3/53 • Number of events 3 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	6.7% 3/45 • Number of events 3 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Gastrointestinal disorders Vomiting	1.9% 1/53 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	6.7% 3/45 • Number of events 3 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Gastrointestinal disorders Anorexia	7.5% 4/53 • Number of events 4 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	0.00% 0/45 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Blood and lymphatic system disorders Neutropenia	13.2% 7/53 • Number of events 7 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	0.00% 0/45 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Gastrointestinal disorders Diarrhea	0.00% 0/53 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	4.4% 2/45 • Number of events 2 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Gastrointestinal disorders Hematemesis	0.00% 0/53 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	2.2% 1/45 • Number of events 2 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Progressive Disease-Brain Mets	0.00% 0/53 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	2.2% 1/45 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
General disorders Increasing Abdominal Girth	0.00% 0/53 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	2.2% 1/45 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	0.00% 0/53 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	2.2% 1/45 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/53 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	4.4% 2/45 • Number of events 2 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Metabolism and nutrition disorders Increased Bilirubin	0.00% 0/53 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	2.2% 1/45 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
General disorders Fever	0.00% 0/53 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	2.2% 1/45 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
General disorders Malaise	0.00% 0/53 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	2.2% 1/45 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Nervous system disorders Syncope	0.00% 0/53 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	2.2% 1/45 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Vascular disorders Pulmonary Embolism	0.00% 0/53 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	2.2% 1/45 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Cardiac disorders Ventricular Tachycardia	0.00% 0/53 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	2.2% 1/45 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
Gastrointestinal disorders Gastric Outlet Obstruction	0.00% 0/53 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	2.2% 1/45 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.
General disorders Death	— 0/0 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.	2.2% 1/45 • Number of events 1 • Adverse event (AE) reporting from time of first intervention, before each dose of chemotherapy (every 14 days) to follow-up 90 days after end of treatment. NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting.