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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Sanofi-Aventis City of Hope National Medical Center Piedmont Hospital Research Institute (PHRI) Medical College of Wisconsin QUEENS HEALTH NETWORK/QUEENS HOSP Weill Medical College of Cornell University University of Massachusetts Memorial Cancer Institute |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00515411 |
Combination chemotherapy given together is a standard way to treat 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 performed to find out if these three drugs can be given more safely and with fewer side effects and still maintain the same survival rate benefit as the standard way of giving this three drug combination.
The investigators can reduce side effects by giving chemotherapy with medicine to boost the infection fighting cells during treatment. The investigators can also give lower doses of the chemotherapy more often. At this time, the investigators do not know which way the treatment works best. The investigators therefore wish to study both of these options. This trial will be a randomized trial, which means that if the patient agrees to participate in the trial, he/she will be assigned by random selection (such as in a flip of a coin) to receive either the original schedule of docetaxel, cisplatin, and fluorouracil with the addition of a medicine to boost the immune system, or lower and more frequent doses of docetaxel, cisplatin, and fluorouracil. Neither the patient nor the doctor will be able to select which arm of the study the patient is assigned to. This is an open-label trial, which means that both the patient and the doctor will be informed of which treatment arm the patient is receiving.
Condition | Intervention | Phase |
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Gastroesophageal Junction Adenocarcinoma Gastric Cancer |
Drug: Docetaxel, Leucovorin, Fluorouracil, Cisplatin Drug: Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Random Assignment Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) With Growth Factor Support in Patients With Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma |
Estimated Enrollment: | 120 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A, - Modified DCF: Active Comparator
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) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments). |
Drug: Docetaxel, Leucovorin, Fluorouracil, Cisplatin
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)
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ARM B - Parent DCF with G-CSF: Active Comparator
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 |
Drug: Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen
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. |
To determine the efficacy of modified docetaxel, cisplatin, and fluorouracil (mDCF) (ARM A) and the efficacy of parent DCF with growth factor support (ARM B) in patients with unresectable or metastatic gastric or gastroesophageal junction(GEJ) adenocarcinoma as measured by 6 month progression free survival (PFS).
To establish the safety of mDCF and parent DCF with growth factor support in patients with unresectable or metastatic gastric or GEJ adenocarcinoma.
To observe other measures of efficacy of mDCF and parent DCF with growth factor support, including response rate, median PFS, overall and 1-year survival in patients with unresectable or metastatic gastric or GEJ adenocarcinoma.
To explore the association of early FDG-PET imaging with treatment efficacy. To explore the differences in docetaxel pharmacology between both study arms. To bank tumor biopsy material for future planned correlative studies for association with chemotherapy efficacy and survival.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hematologic (minimal values):
Hepatic (minimal values):
Kidney function (minimal values):
* Serum creatinine < than or = to 1.5 mg/dl - if serum creatinine is 1.2-1.5 mg/dl, the creatinine clearance (either measured or calculated) must be 50 ml/min or greater
The patient has a PT (INR) < than or = to 1.5 and an PTT < than or = to 3 seconds above the upper limits of normal if the patient is not on anticoagulation. If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment:
Exclusion Criteria:
Contact: Manish Shah, MD | (212) 639-3113 | shah1@mskcc.org |
Contact: David Kelsen, MD | (212) 639-8470 | kelsend@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering Cancer Center 1275 York Avenue | Recruiting |
New York, New York, United States, 10021 | |
Contact: Manish Shah, MD 212-639-3113 shah1@mskcc.org | |
Principal Investigator: Manish Shah, MD |
Principal Investigator: | Manish Shah, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center ( Manish Shah, MD ) |
Study ID Numbers: | 06-103 |
Study First Received: | August 10, 2007 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00515411 |
Health Authority: | United States: Institutional Review Board |
gastroesophageal junction gastric cancer adenocarcinoma unresectable gastric cancer metastatic gastric |
Digestive System Neoplasms Gastrointestinal Diseases Leucovorin Stomach cancer Carcinoma Docetaxel Digestive System Diseases |
Stomach Diseases Cisplatin Stomach Neoplasms Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial |
Antimetabolites Vitamin B Complex Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Vitamins Therapeutic Uses Micronutrients |