Study of Docetaxel, Cisplatin, and Fluorouracil (Modified DCF) With Bevacizumab in Patients With Unresectable or Metastatic Gastroesophageal Adenocarcinoma

NCT00390416 | Completed Phase 2 Results

• 1 other identifier: 06-096
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Keywords

Metastatic; Gastroesophageal; Docetaxel; Cisplatin; Fluorouracil; Bevacizumab; Metastatic Gastroesophageal Adenocarcinoma; 06-096

Outcome Measures

Primary Outcomes (2)

• 6 Month Progression Free Survival

  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

  1 year

Secondary Outcomes (1)

• Patients With Measurable Disease the Confirmed Response Rate

  up to 2 years

Study Arms (1)

Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin

EXPERIMENTAL

Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin

Drug: Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin

Interventions

Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin DRUG

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

Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Sanofi: collaborator
• Genentech, Inc.: collaborator

Study Sites (5)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan-Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan-Kettering Cancer Center 1275 York Avenue

New York, New York, 10021, United States

Location

Memorial Sloan-Kettering Cancer Center at Mercy Medical Center

Rockville Centre, New York, 11570, United States

Location

Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital

Sleepy Hollow, New York, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms; Neoplasm Metastasis

Interventions

Docetaxel; Cisplatin; Fluorouracil; Bevacizumab; Leucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Dr. David Ilson
• Organization: Memorial Sloan Kettering Cancer Center

ilsond@mskcc.org

646-888-4183

Study Officials

• David Ilson, MD,PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2006
• First Posted: October 19, 2006
• Study Start: October 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 14, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Locations

US (5)