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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00390416
Phase
PHASE2
Status
Completed

Conditions

  • Esophageal Neoplasms
  • Stomach Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Oct 19, 2006
Start date
Oct 31, 2006
Status verified
Feb 2016
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
    Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin

Primary Outcome Measure

6 Month Progression Free Survival [ Time Frame: 6 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Memoral Sloan Kettering Cancer CenterBasking RidgeNew Jersey--
Memorial Sloan-Kettering Cancer Center @ SuffolkCommackNew York11725-
Memorial Sloan-Kettering Cancer Center 1275 York AvenueNew YorkNew York10021-
Memorial Sloan-Kettering Cancer Center at Mercy Medical CenterRockville CentreNew York11570-
Memoral Sloan Kettering Cancer Center@Phelps Memorial HospitalSleepy HollowNew York--

Find similar trials in Basking Ridge, NJ

By research site
Memoral Sloan Kettering Cancer Center· Basking Ridge, NJMemorial Sloan-Kettering Cancer Center @ Suffolk· Commack, NYMemorial Sloan-Kettering Cancer Center 1275 York Avenue· New York, NYMemorial Sloan-Kettering Cancer Center at Mercy Medical Center· Rockville Centre, NYMemoral Sloan Kettering Cancer Center@Phelps Memorial Hospital· Sleepy Hollow, NY

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