Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction
An Evaluation of Preoperative Chemotherapy With Irinotecan and Cisplatin for Advanced, But Resectable Gastric Cancer: A Coordinated Multidisciplinary, Multicenter Study Linking Functional Imaging, Genomic Expression Profiles and Histopathology
7 other identifiers
interventional
55
1 country
1
Brief Summary
This phase II trial is studying how well giving irinotecan together with cisplatin works in treating patients who are undergoing surgical resection for locally advanced cancer of the stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them before surgery may shrink the tumor so that it can be removed during surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2003
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 5, 2003
CompletedFirst Posted
Study publicly available on registry
June 6, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
July 6, 2017
CompletedJuly 6, 2017
June 1, 2017
8 years
June 5, 2003
September 22, 2014
June 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Histological Response Determined by FDG Uptake Correlates
The primary objective was to demonstrate that a decrease in FDG-SUV discriminates treatment response. Response was defined pathologically based on microscopic inspection for residual cancer cells and fibrosis. Using a two sample t-test, we would be able to adequately test that the decrease in SUV early in the treatment plan is significantly different between responders and non responders. Data adjudication was invalid, and needs to be re-adjudicated Non-Responder= Tumor Regression Grade 3 or higher Responder=Tumor Regression Grade 1 (CR) or Grade 2 (PR)
Day 15
Other Outcomes (1)
Disease Free Survival (DFS)
Every 3 mos for the first 2 yrs, then every 6 mos for 2 years and once a year afterwards, up to 5 years
Study Arms (1)
Treatment (preoperative chemotherapy)
EXPERIMENTALNeoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection.
Interventions
Given IV
Undergo FDG and FLT PET/CT
Undergo FDG-PET/CT
Undergo FLT-PET/CT
Given IV
Undergo FDG and FLT PET/CT
Undergo radical subtotal or total gastrectomy with lymph node dissection
Eligibility Criteria
You may qualify if:
- All patients must have microscopically confirmed adenocarcinoma of the stomach or gastroesophageal (GE) junction with material reviewed by the Department of Pathology of the participating Institution; tumors involving the GE junction must have the bulk of their disease in the stomach; tumors of the distal esophagus that extend less than 2cm into the stomach are ineligible for this study; using the Siewert's classification for the GE junction, tumors designated as Types II and III are indeed considered eligible for this clinical trial
- All patients must have localized cancer potentially curable by surgery; the tumor stage should be Tany N+ M0 or T3-T4 Nany M0, by staging that includes a computed tomography (CT) scan and either laparoscopy-assisted pancreatobiliary (LAP) or endoscopic ultrasound (EUS); patients with T1-2N0M0 tumors, confirmed by LAP ("good risk") are ineligible; any sites of suspected M1 disease by these criteria must be proven to be M0 prior to entrance into a neoadjuvant trial
- Patients must have a Karnofsky Performance Status \>= 60% (Eastern Cooperative Oncology Group \[ECOG\] =\< 2) and be able to tolerate the proposed surgical procedure and chemotherapy regimen
- Patients may not have received prior chemotherapy or radiation for this disease
- Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3
- Platelets \>= 100,000/mm\^3
- Serum creatinine =\< 1.5 mg/dL
- Total serum bilirubin =\< 1.5 mg/dL
- Patients must have signed informed consent indicating that they are aware of the investigational nature of the study and that participation is voluntary
- No clinically significant auditory impairment
- No clinically significant peripheral neuropathy
- New York Heart Association (NYHA) class I-II
- Patients must not have a prior history of cancer within the last five years except for non-melanoma skin cancer, non-metastatic prostate cancer or carcinoma in situ of the uterine cervix
You may not qualify if:
- Any metastatic disease
- NYHA Class III or IV heart disease; history of active angina or myocardial infarction within 6 months; history of significant ventricular arrhythmia requiring medication with antiarrhythmics or a history of a clinically significant conduction system abnormality
- Pregnant or lactating women are ineligible; fertile men and women, unless using effective contraception, are ineligible; a pregnancy test will be performed on sexually active women of childbearing potential prior to entry into the study; treatment may not begin until the results of the pregnancy test are ascertained
- Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy
- Grade 2 or greater pre-existing peripheral neuropathy
- Psychiatric disorders rendering patients incapable of complying with the requirements of the protocol
- Any concurrent active malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer or carcinoma-in-situ of the uterine cervix; patients with previous malignancies but without evidence of disease for \> 5 years will be allowed to enter the trial
- Clinically significant hearing loss
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Technical problems with measurement leading to unreliable or uninterpretable data. Data adjudication was invalid, and needs to be re-adjudicated.
Results Point of Contact
- Title
- Dr. David P. Kelsen
- Organization
- Memorial Sloan-Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Manisha Shah
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2003
First Posted
June 6, 2003
Study Start
June 1, 2003
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
July 6, 2017
Results First Posted
July 6, 2017
Record last verified: 2017-06