Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
A Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Patients With Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
1 other identifier
interventional
111
1 country
15
Brief Summary
Chemotherapy given together is a standard way to treat your cancer. One standard treatment includes a combination of docetaxel, cisplatin, and fluorouracil. However, the original combination of these three drugs can cause many side effects. This study is being done to find out if these three drugs can be given at lower doses more often, with fewer side effects and still maintain the same benefit as the standard way of giving this three drug combination. If your tumor overexpresses a protein called Her2, you are also eligible to receive trastuzumab with chemotherapy. Trastuzumab is a medicine that has been approved by the US Food and Drug Administration for the treatment of Her2 positive breast cancer. Trastuzumab is now also a standard treatment in combination with chemotherapy for the treatment of Her2 positive stomach cancer. If your tumor is Her2 positive, you would receive the modified administration schedule of docetaxel, cisplatin, and fluorouracil with trastuzumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2006
Longer than P75 for phase_2
15 active sites
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
October 23, 2006
CompletedFirst Submitted
Initial submission to the registry
August 10, 2007
CompletedFirst Posted
Study publicly available on registry
August 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2018
CompletedResults Posted
Study results publicly available
December 10, 2019
CompletedDecember 10, 2019
October 1, 2018
12 years
August 10, 2007
October 31, 2019
November 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6 Month Progression Free Survival (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 lesions", or similar definition as accurate and appropriate
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Secondary Outcomes (1)
Overall Survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 43 months
Study Arms (3)
Arm A, - Modified DCF
ACTIVE COMPARATORDrug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).
ARM B - Parent DCF with G-CSF
ACTIVE COMPARATORDocetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17 \* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg
Arm C - Modifid DCF + Trastuzumab
ACTIVE COMPARATORTreatment for Her2 Positive Participants Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes.
Interventions
Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)
Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17 \* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter.
Treatment for Her2 Positive Participants Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes.
Eligibility Criteria
You may qualify if:
- Patients must have histologically or cytologically confirmed metastatic or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. GEJ adenocarcinoma may be classified according to Siewert's classification type I, II, or III\[43\].
- Histological documentation of local recurrence or metastasis is strongly encouraged, unless the risk of such a procedure outweighs the potential benefit of confirming the metastatic disease.
- If no histologic confirmation, then the metastases or recurrence will require documentation by a 2nd radiographic procedure (eg. PET/CT scan or MRI in addition to the CT scan). If the imaging procedure does not confirm recurrent or metastatic disease, biopsy confirmation will be required.
- Patients must have disease that can be evaluated radiographically. This may be measurable disease or non-measurable disease. Measurable disease is defined as that which can be measured in at least one dimension as \> 20 mm with conventional techniques, or \>10 mm by high resolution imaging. Disease that is identified on radiology studies, but does not meet the criteria for measurable disease, is considered non-measurable.
- Patients may have received no prior chemotherapy for metastatic or unresectable disease. Patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration. Patients may not have received prior docetaxel or cisplatin.
- Age 18 years or older.
- Karnofsky performance status \> than or = to 70% (ECOG performance status 0-1).
- Peripheral neuropathy \< than or = to grade 1.
- Hematologic (minimal values):
- White blood cell count \> than or = to 3000/mm3
- Absolute neutrophil count \> than or = to 1500 cells/ mm3
- Hemoglobin \> than or = to 9.0 g/dl
- Platelet count \> than or = to 100,000 / mm3
- Hepatic (minimal values):
- Total bilirubin \< or = to 1.5
- +11 more criteria
You may not qualify if:
- Patients who have received previous chemotherapy for the treatment of metastatic or unresectable gastric or GEJ adenocarcinoma are ineligible.
- Patients who have received previous pre- or post-operative chemotherapy or chemoradiation are ineligible if therapy was completed less than 6 months prior to study registration. Patients must have recovered from adverse events from any previous therapy.
- Patients who have received previous docetaxel or cisplatin.
- Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
- Patients with brain or central nervous system metastases, including leptomeningeal disease.
- Pregnant (positive pregnancy test) or breast feeding.
- Serious, non-healing wound, ulcer, or bone fracture.
- Significant cardiac disease as defined as:
- unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months
- Evidence of bleeding diathesis or coagulopathy.
- History of a stroke or CVA within 6 months
- Clinically significant peripheral vascular disease.
- Clinically significant hearing loss or ringing in the ears.
- Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
- Inability to comply with study and/or follow-up procedures.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Sanoficollaborator
- Roche-Genentechcollaborator
- City of Hope National Medical Centercollaborator
- Piedmont Hospital Research Institutecollaborator
- Medical College of Wisconsincollaborator
- Queens Health Networkcollaborator
- Weill Medical College of Cornell Universitycollaborator
- Memorial Cancer Institute, Floridacollaborator
- University of Pittsburghcollaborator
- Long Island Jewish Medical Centercollaborator
- Nebraska Cancer Specialists Methodist Estabrook Cancer Centercollaborator
Study Sites (15)
City of Hope Cancer Center
Duarte, California, 91010, United States
Memorial Cancer Institute
Pembroke Pines, Florida, 33025, United States
Piedmont Hospital Research Institute
Atlanta, Georgia, 30309, United States
Nebraska Cancer Specialists, Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114, United States
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center 1275 York Avenue
New York, New York, 10065, United States
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
Sleepy Hollow, New York, United States
University Hospital of Cleveland
Cleveland, Ohio, 44106, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
Mondaca S, Margolis M, Sanchez-Vega F, Jonsson P, Riches JC, Ku GY, Hechtman JF, Tuvy Y, Berger MF, Shah MA, Kelsen DP, Ilson DH, Yu K, Goldberg Z, Epstein AS, Desai A, Chung V, Chou JF, Capanu M, Solit DB, Schultz N, Janjigian YY. Phase II study of trastuzumab with modified docetaxel, cisplatin, and 5 fluorouracil in metastatic HER2-positive gastric cancer. Gastric Cancer. 2019 Mar;22(2):355-362. doi: 10.1007/s10120-018-0861-7. Epub 2018 Aug 7.
PMID: 30088161DERIVEDShah MA, Janjigian YY, Stoller R, Shibata S, Kemeny M, Krishnamurthi S, Su YB, Ocean A, Capanu M, Mehrotra B, Ritch P, Henderson C, Kelsen DP. Randomized Multicenter Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (DCF) Versus DCF Plus Growth Factor Support in Patients With Metastatic Gastric Adenocarcinoma: A Study of the US Gastric Cancer Consortium. J Clin Oncol. 2015 Nov 20;33(33):3874-9. doi: 10.1200/JCO.2015.60.7465.
PMID: 26438119DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Yelena Janjigian, MD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Yelena Janjigian, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2007
First Posted
August 13, 2007
Study Start
October 23, 2006
Primary Completion
October 26, 2018
Study Completion
October 26, 2018
Last Updated
December 10, 2019
Results First Posted
December 10, 2019
Record last verified: 2018-10