Study of 5-Fluorouracil and Leucovorin and Intra-Abdominal Floxuridine Chemoradiation in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma
This study has been completed.
Sponsor:
USC/Norris Comprehensive Cancer Center
Collaborators:
New York University School of Medicine
Information provided by:
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00183911
First received: September 9, 2005
Last updated: January 10, 2008
Last verified: May 2006
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Purpose
The purpose of this study is to evaluate the side effects of a new treatment for stomach cancer which may potentially improve the prognosis of this cancer.
Our principle objective is to improve the results of standard chemotherapy and radiation after surgery of patients with gastric cancer. The intra-abdominal (intraperitoneal) administration of floxuridine (FUDR) is a procedure that we have studied and have determined it is a safe treatment. In this study, we want to evaluate the side effects of this treatment when it is given after surgery but before standard intravenous chemotherapy and radiation.
Study treatment will start with surgical removal of the part of the stomach with cancer, together with surrounding tissues and lymph nodes. After surgery, patients will get treatment with a chemotherapy drug, FUDR, administered directly into the abdomen. This is called intraperitoneal chemotherapy. After this treatment patients will receive repeated intravenous injection of two drugs, 5-fluorouracil and leucovorin alone or combined with irradiation of the abdomen.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Adenocarcinoma Gastric Cancer |
Drug: floxuridine, 5-Fluorouracil, leucovorin Procedure: External Beam Radiotherapy Procedure: Surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Adjuvant Intraperitoneal FUDR Treatment Added to Chemoradiation (5-Fluorouracil/Leucovorin Plus Total Dose 4500 cGy of External Beam Radiotherapy) in Patients With Fully Resected Locally Advanced Gastric Adenocarcinoma |
Resource links provided by NLM:
Further study details as provided by USC/Norris Comprehensive Cancer Center:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologic dx of locally advanced gastric adenocarcinoma (requires upper endoscopy with bx of lesion and CT scan of chest, abdomen, and pelvis with iv and oral contrast or other methods of imaging to confirm absence of metastatic dz) (Untreated patients with histologically documented gastric/GEJ ca stages IB-IV [M0] are eligible)
- Based on post-op pathological findings, diagnosis and staging has to confirm stage IB-IV (M0) adenocarcinoma of stomach or GEJ.
- Patients who underwent emergency surgery for indications such as GI obstruction, perforation, or hemorrhage, or patients with surgery already performed, are eligible provided surgery is considered curative
- ECOG performance status 0-2
- AGC greater than or equal to 1.5; platelets greater than or equal to 100,000; Hgb greater than or equal to 9.0· Total bilirubin less than or eqal to 2.0; SGOT/SGPT less than or equal to 2.5 x uln; alk phos less than or equal to 2.5 x uln
- BUN less than or equal to 30; creatinine less than or equal to 1.5 or CrCl >60 ml/min
- Negative b-HCG pregnancy test (females with reproductive potential)
- PT, aPTT, and thrombin time within range of normal
- Evidence of at least unilateral renal function as established by CT scan with contrast or nephrogram. (If only one kidney is present, at least 2/3 of the functioning kidney must be excluded from any RT port)
Exclusion Criteria:
- Prior radiation therapy, chemotherapy or immunotherapy
- Presence of another active invasive malignancy (Except for adequately treated basal cell or squamous cell skin ca, in-situ cervical ca, or other cancer for which patient has been disease-free for at least 5 yrs)
- Active or uncontrolled infection, including HIV
- Psychiatric disorders that would interfere with informed consent· Pregnant or nursing women (Patients of reproductive age must agree to use effective contraceptive method)
- Any other severe concurrent disease, which in the judgment of MD would make patient inappropriate for study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183911
Locations
| United States, California | |
| U.S.C. / Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
Sponsors and Collaborators
USC/Norris Comprehensive Cancer Center
New York University School of Medicine
Investigators
| Study Chair: | Syma Iqbal, M.D. | U.S.C./Norris Comprehensive Cancer Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00183911 History of Changes |
| Other Study ID Numbers: | 3G-03-1 |
| Study First Received: | September 9, 2005 |
| Last Updated: | January 10, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Floxuridine |
Fluorouracil Leucovorin Levoleucovorin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients |
ClinicalTrials.gov processed this record on June 18, 2013