- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00390416
Study of Docetaxel, Cisplatin, and Fluorouracil (Modified DCF) With Bevacizumab in Patients With Unresectable or Metastatic Gastroesophageal Adenocarcinoma
February 16, 2016 updated by: Memorial Sloan Kettering Cancer Center
A Phase II Study of Docetaxel, Cisplatin, and Fluorouracil (Modified DCF) With Bevacizumab in Patients With Unresectable or Metastatic Gastroesophageal Adenocarcinoma
This study is being done to find out what effects a drug named/called bevacizumab has on patients and patients' tumors when given together with standard chemotherapy drugs.
Making new blood vessels seems to be important for many tumors to grow.
Bevacizumab is a new type of treatment for cancer that blocks the growth of new tumor blood vessels.
In this study, the researchers will combine bevacizumab with chemotherapy drugs that are standard for the patient's disease and include cisplatin, docetaxel, fluorouracil, and leucovorin.
The way the original combination of cisplatin, docetaxel, and fluorouracil was given caused many side effects including gastrointestinal symptoms, weakness, and a drop in the blood count of infection fighting cells.
For this study, the researchers have modified this combination to give lower doses of the medicines more often, to reduce side effects from the chemotherapy.
Patients will receive bevacizumab with this modified combination of docetaxel, cisplatin, and fluorouracil.
This study is called a phase II study.
In this study, everyone will have similar tumors and receive the same treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Basking Ridge, New Jersey, United States
- Memoral Sloan Kettering Cancer Center
-
-
New York
-
Commack, New York, United States, 11725
- Memorial Sloan-Kettering Cancer Center @ Suffolk
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center 1275 York Avenue
-
Rockville Centre, New York, United States, 11570
- Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
-
Sleepy Hollow, New York, United States
- Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed metastatic or unresectable gastric or esophageal adenocarcinoma, including GEJ adenocarcinoma which will be classified according to Siewert's classification type I, II, or III.
- 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 (i.e. positron emission tomography [PET] scan or magnetic resonance imaging [MRI] in addition to the computed tomography [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 > or = 20 mm with conventional techniques, or > 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 - see section 12.1.1 of protocol for further details.
- 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, or bevacizumab or any other novel biologic anti-angiogenic agent.
- Age 18 years or older.
- Karnofsky performance status > or = 70% (ECOG performance status 0-1).
- Peripheral neuropathy < or = grade 1
Hematologic (minimal values):
- White blood cell count > or = 3000/mm3
- Absolute neutrophil count > or = 1500 cells/mm3
- Hemoglobin > or = 9.0 g/dl
- Platelet count > or = 100,000/mm3
Hepatic (minimal values):
- Total bilirubin < or = to upper limit of normal (ULN)
- AST and ALT and alkaline phosphatase must be within the eligible range. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used. AST and ALT and alkaline phosphatase should be no more than 1-1.5 times the upper limit of normal.
Kidney function (minimal values):
- Serum creatinine < or = 1.5 mg/dl
- Urinalysis < 2+ proteinuria; urine protein (mg/dl)/urine creatinine (mg/dl) ratio (Up/c) < 1.0
The patient has a PT (INR) < or = 1.5 and a PTT < or = 3 seconds above the upper limits of normal if the patient is not on anticoagulation therapy. If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment:
- The patient must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of LMW heparin.
- The patient must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices).
- Women of childbearing potential must have a negative pregnancy test. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- Ability to understand informed consent and signing of written informed consent document prior to initiation of protocol therapy.
Exclusion Criteria:
- Patients who have received previous chemotherapy for the treatment of metastatic or unresectable gastric, GEJ, or esophageal 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 bevacizumab, 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.
- Minor surgical procedure such as fine needle aspiration, core biopsy, laparoscopy, or mediport placement within 7 days prior to initiating treatment.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0
- Anticipation of need for major surgical procedure during the course of the study.
- Pregnant (positive pregnancy test) or breast feeding.
- Urine protein:creatinine (Up/c) ratio > or = 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to the initiation of treatment.
- Serious, non-healing wound, ulcer, or bone fracture.
- Blood pressure > 150/100 mmHg
Significant cardiac disease 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 cerebrovascular accident (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.
- Patients with any other medical condition or reason, in the investigator's opinion, that makes the patient unstable to participate in a clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
|
Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 Month Progression Free Survival
Time Frame: 6 months
|
as measured from the start of the treatment to the date of either documentation of disease progression or death.
As we have previously, we will define progression of disease as per RECIST criteria.
As per RECIST criteria, any evidence of progression in non-measurable lesions, measurable lesions, or the development of new lesions, would qualify as disease progression .RECIST criteria as defined by CTEP (http://ctep.info.nih.gov/Policies).
|
6 months
|
1-year Survival
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patients With Measurable Disease the Confirmed Response Rate
Time Frame: up to 2 years
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David Ilson, MD,PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
October 17, 2006
First Submitted That Met QC Criteria
October 18, 2006
First Posted (Estimate)
October 19, 2006
Study Record Updates
Last Update Posted (Estimate)
March 14, 2016
Last Update Submitted That Met QC Criteria
February 16, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms
- Stomach Neoplasms
- Adenocarcinoma
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protective Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Docetaxel
- Cisplatin
- Fluorouracil
- Bevacizumab
- Leucovorin
Other Study ID Numbers
- 06-096
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stomach Neoplasms
-
Jeeyun LeeRecruitingStomach Cancer, AdenocarcinomaKorea, Republic of
-
Chinese University of Hong KongUnknown
-
Chinese University of Hong KongUnknown
-
National Cancer Center, KoreaUnknownSubmucosal Tumor of StomachKorea, Republic of
-
Xijing Hospital of Digestive DiseasesCompletedStomach Cancer | Esophageal Cancer | Esophageal Dysplasia | Stomach DysplasiaChina
-
Chinese University of Hong KongRecruiting
-
Universitätsklinikum Hamburg-EppendorfOvesco Endoscopy AGSuspendedSubmucosal Tumor of StomachGermany
-
Soonchunhyang University HospitalCompletedMalignant Neoplasm of Stomach | Benign Neoplasm of StomachKorea, Republic of
-
Fujian Cancer HospitalCompletedMalignant Neoplasm of Stomach Stage IVChina
-
Federation Francophone de Cancerologie DigestiveEli Lilly and CompanyActive, not recruitingStomach Cancer | Gastric Cancer | Gastroesophageal Junction Adenocarcinoma | Stomach NeoplasmFrance
Clinical Trials on Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
-
Memorial Sloan Kettering Cancer CenterSanofi; University of Pittsburgh; Medical College of Wisconsin; Weill Medical College... and other collaboratorsCompletedGastric Cancer | Gastroesophageal Junction AdenocarcinomaUnited States
-
Sun Yat-sen UniversityRecruitingNasopharyngeal Carcinoma | Circulating Tumor Cell | Effects of Chemotherapy | Distant Metastases.ClinicalChina
-
Mario Negri Institute for Pharmacological ResearchAventis Pharmaceuticals; Istituto Scientifico Romagnolo per lo Studio e la... and other collaboratorsCompletedAdenocarcinoma of the Gastroesophageal Junction | Adenocarcinoma of the StomachItaly
-
Yonsei UniversityCompleted
-
Sun Yat-sen UniversityPeking University; Zhejiang Cancer Hospital; Xiangya Hospital of Central South... and other collaboratorsNot yet recruitingNasopharyngeal CarcinomaChina
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)UnknownHead and Neck CancerUnited States
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...CompletedLocally Advanced Resectable Oral Cavity Squamous Cell CancerItaly
-
AIO-Studien-gGmbHNeovii BiotechCompletedGastric Adenocarcinoma With Peritoneal Carcinomatosis | Siewert Type II Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis | Siewert Type III Adenocarcinoma of Esophagogastric Junction With Peritoneal CarcinomatosisGermany
-
Affiliated Cancer Hospital & Institute of Guangzhou...RecruitingNasopharyngeal CarcinomaChina