Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer - Full Text View

Sponsor:	New York University School of Medicine
Collaborator:	National Cancer Institute (NCI)
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00004103

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 II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Floxuridine Cisplatin Irinotecan U 101440E Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Study Start Date:	July 1998
Study Completion Date:	June 2009
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004103

Locations

United States, New York
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

National Cancer Institute (NCI)

Investigators

Study Chair:

Elliot Newman, MD

New York University School of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Newman E, Potmesil M, Ryan T, Marcus S, Hiotis S, Yee H, Norwood B, Wendell M, Muggia F, Hochster H. Neoadjuvant chemotherapy, surgery, and adjuvant intraperitoneal chemotherapy in patients with locally advanced gastric or gastroesophageal junction carcinoma: a phase II study. Semin Oncol. 2005 Dec;32(6 Suppl 9):S97-100.

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 February 12, 2012