Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients
A Phase I/II Study of Docetaxel, 5-Fluorouracil and Oxaliplatin (D-FOX) in Patients With Untreated Locally Unresectable or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction
2 other identifiers
interventional
98
1 country
1
Brief Summary
Phase I Objectives Primary: 1\. The primary objective of this study is to determine the maximum tolerated dose (MTD) of Docetaxel combined with 5-Fluorouracil and Oxaliplatin (D-FOX) in patients with untreated, locally unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ). Secondary: 1\. To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination. Phase II Objectives Primary: 1\. To assess time to cancer progression to D-FOX treatment regimen. Secondary:
- 1.To assess response rate to D-FOX treatment regimen.
- 2.To determine the qualitative and quantitative toxicity and reversibility of toxicity of this combination treatment regimen.
- 3.Determine overall survival.
- 4.Perform an exploratory investigation into the effect of D-FOX on phenotypic abnormalities in blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2004
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 4, 2007
CompletedFirst Posted
Study publicly available on registry
September 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
October 31, 2016
CompletedOctober 31, 2016
September 1, 2016
10.8 years
September 4, 2007
June 28, 2016
September 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum Tolerated Dose (MTD)
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).
28 days
Progression Free Survival
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.
Assessed from baseline to 30 months
Secondary Outcomes (1)
Median Overall Survival
Up to 30 months
Study Arms (1)
5-Fluorouracil + Docetaxel + Oxaliplatin
EXPERIMENTAL5-Fluorouracil 2.2 Gm/m\^2 intravenously (IV) over 48 hours on Day 1. Docetaxel 20 mg/m\^2 IV over 60 minutes. Oxaliplatin 85 mg/m\^2 IV over 120 minutes on Day 1.
Interventions
2.2 Gm/m\^2 IV over 48 hours on Day 1.
20 mg/m\^2 IV over 60 minutes
85 mg/m\^2 IV over 120 minutes on Day 1.
Eligibility Criteria
You may qualify if:
- Histologically documented adenocarcinoma of the stomach or Gastroesophageal Junction (GEJ).
- Age \>18 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;
- Chemotherapy: No prior chemotherapy is permitted for metastatic disease. Use of prior chemotherapy in the adjuvant and/or neo-adjuvant setting or as part of a radiosensitization is permitted, provided that the minimum time from completion of such treatment to study entry is at least 12 months;
- Radiation: Patients may have had prior radiation therapy that has not exceeded 25% of bone marrow reserve provided that they have recovered from the acute, toxic effects of radiotherapy prior to registration. A minimum of 14 days must have elapsed since the end of radiotherapy.
- Previous Surgery: Previous surgery is permitted provided that wound healing has occurred prior to registration. Minimum of 14 days must have elapsed between a major surgery and start of chemotherapy.
- At least one target lesion \>20 mm (or \>10 mm on spiral CT-scan). If indicator lesions are in a previously irradiated field, only a clear disease progression of the irradiated lesion or a new lesion in the previously irradiated field will be accepted
- Adequate baseline bone marrow, hepatic and renal function, defined as follows: Neutrophils \>1.5 \* 10\*9/L and platelets \>100 \* 10\*9/L; Bilirubin \<1.5 \* upper limit of the normal range (ULN); aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT) \<2.5 \* ULN; Serum creatinine \<1.5 \* ULN;
- Patients must give written informed consent to participate in the study.
- Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of child-bearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to registration.
You may not qualify if:
- Concurrent anticancer therapy
- Pregnant or lactating women
- History of other prior malignancy except for adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer or malignancy from which the patient has been disease-free for 5 years;
- Brain metastases
- Patients with active or uncontrolled infections or with serious illnesses or medical conditions, including patients with a history of chronic alcohol abuse, hepatitis, HIV and/or cirrhosis
- History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent.
- Known hypersensitivity to any of the drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Sanofi-Synthelabocollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Blum Murphy MA, Qiao W, Mewada N, Wadhwa R, Elimova E, Takashi T, Ho L, Phan A, Baker J, Ajani J. A Phase I/II Study of Docetaxel, Oxaliplatin, and Fluorouracil (D-FOX) Chemotherapy in Patients With Untreated Locally Unresectable or Metastatic Adenocarcinoma of the Stomach and Gastroesophageal Junction. Am J Clin Oncol. 2018 Apr;41(4):321-325. doi: 10.1097/COC.0000000000000271.
PMID: 26908161RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jaffer Ajani, MD/Professor, GI Medical Oncology
- Organization
- The University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jaffer Ajani, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2007
First Posted
September 6, 2007
Study Start
August 1, 2004
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
October 31, 2016
Results First Posted
October 31, 2016
Record last verified: 2016-09