Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying how well irinotecan and cisplatin followed by surgery, floxuridine, and cisplatin work in treating patients with stomach cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: cisplatin Drug: floxuridine Drug: irinotecan hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Systemic Therapy With CPT-11 (Camptosar HCl) and Cisplatin in Patients With Advanced Gastric Cancer to be Followed by Surgical Resection and Postoperative Intraperitoneal Chemotherapy |
| Study Start Date: | July 1998 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the complete and partial response rates and time to treatment failure in patients with advanced gastric cancer treated with neoadjuvant irinotecan and cisplatin followed by surgery then intraperitoneal floxuridine and cisplatin.
- Determine the rate of potentially curative surgery in patients receiving this regimen.
- Determine the toxicity and tolerance of this regimen in these patients.
OUTLINE: Patients receive cisplatin IV and irinotecan IV once a week for 4 weeks. This course is repeated 2 weeks later.
Patients who achieve complete or partial remission or stable disease undergo resection 4 weeks after the last chemotherapy dose.
Patients with no residual macroscopic disease begin adjuvant intraperitoneal (IP) chemotherapy 1 week after surgery. Chemotherapy consists of floxuridine IP over 30 minutes on days 1-3 and days 22-24 and cisplatin IP on days 3 and 24.
PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven, previously untreated gastric cancer
- Stage IB, II, III, or IV (T3-4, N0 OR any T, N1-2, M0)
- No metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- SWOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 4000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic:
- Bilirubin less than 2 mg/dL
- SGOT/SGPT no greater than 2 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 3 times ULN
- PT, aPTT, and TT normal
- No Gilbert's disease
Renal:
- BUN no greater than 30 mg/dL
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No myocardial infarction within the past 3 months
- No congestive heart failure requiring therapy
Other:
- No other invasive malignancy in the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
- No active or uncontrolled infection
- HIV negative
- No other severe concurrent disease
- No psychiatric disorders that would preclude compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for gastric cancer
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for gastric cancer
Surgery:
- No prior surgery for gastric cancer
- No emergent need for surgery for gastrointestinal obstruction, perforation, or hemorrhage
Contacts and Locations| United States, New York | |
| NYU Cancer Institute at New York University Medical Center | |
| New York, New York, United States, 10016 | |
| Study Chair: | Elliot Newman, MD | New York University School of Medicine |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00004103 History of Changes |
| Other Study ID Numbers: | CDR0000067322, P30CA016087, NYU-9822, P-UPJOHN-647597196, NCI-G99-1594 |
| Study First Received: | December 10, 1999 |
| Last Updated: | April 5, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by New York University School of Medicine:
|
stage I gastric cancer stage II gastric cancer stage III gastric cancer stage IV gastric cancer |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Irinotecan Cisplatin Floxuridine Camptothecin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013