Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction
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| ClinicalTrials.gov Identifier: NCT00062374 |
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Recruitment Status :
Completed
First Posted : June 6, 2003
Results First Posted : July 6, 2017
Last Update Posted : July 6, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Adenocarcinoma Stage II Gastric Cancer Stage III Gastric Cancer Stage IV Gastric Cancer | Drug: Cisplatin Procedure: Computed Tomography Radiation: Fludeoxyglucose F-18 Other: Fluorothymidine F-18 Drug: Irinotecan Hydrochloride Procedure: Positron Emission Tomography Procedure: Therapeutic Conventional Surgery | Phase 2 |
PRIMARY OBJECTIVES:
I. To evaluate the correlation of fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) imaging early in the preoperative treatment program of locally advanced gastric cancer with histologic response assessment and patient outcome, defined as overall and progression-free survival.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy and safety of preoperative chemotherapy with irinotecan and cisplatin in the treatment of locally advanced gastric cancer.
II. To examine the biology of locally advanced gastric cancer and the response to chemotherapy by DNA microarray technology and by histopathology.
III. To obtain preliminary data on biodistribution, dosimetry and explore the potential clinical usefulness of fluorodeoxythymidine (FLT) PET in patients with locally advanced gastric cancer undergoing a novel combination neoadjuvant chemotherapy.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Neoadjuvant chemotherapy: Patients receive cisplatin intravenously (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.
Patients undergo fluorodeoxyglucose FDG-PET/CT at baseline. Some patients undergo additional FDG-PET/CT scans in weeks 3 and 6. Approximately 5 patients undergo fluorothymidine FLT-PET/CT at baseline, during week 3, and/or before surgical resection.
Patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 55 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | June 2003 |
| Actual Primary Completion Date : | June 2011 |
| Actual Study Completion Date : | June 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (preoperative chemotherapy)
Neoadjuvant 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. |
Drug: Cisplatin
Given IV
Other Names:
Procedure: Computed Tomography Undergo FDG and FLT PET/CT
Other Names:
Radiation: Fludeoxyglucose F-18 Undergo FDG-PET/CT
Other Names:
Other: Fluorothymidine F-18 Undergo FLT-PET/CT
Other Names:
Drug: Irinotecan Hydrochloride Given IV
Other Names:
Procedure: Positron Emission Tomography Undergo FDG and FLT PET/CT
Other Names:
Procedure: Therapeutic Conventional Surgery Undergo radical subtotal or total gastrectomy with lymph node dissection |
- Histological Response Determined by FDG Uptake Correlates [ Time Frame: Day 15 ]
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)
- Disease Free Survival (DFS) [ Time Frame: Every 3 mos for the first 2 yrs, then every 6 mos for 2 years and once a year afterwards, up to 5 years ]Overall Survival (OS) and Disease Free Survival (DFS) are the secondary endpoints. Technical problems with measurement of OS leading to unreliable or uniterpretable data. Data adjudication was invalid, and needs to be re-adjudicated. Therefore, only DFS data is being reported.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062374
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Principal Investigator: | Manisha Shah | Memorial Sloan Kettering Cancer Center |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00062374 |
| Other Study ID Numbers: |
NCI-2012-01438 NCI-2012-01438 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) NCI-5917 CDR0000304738 MSKCC-03032 03-032 ( Other Identifier: Memorial Sloan-Kettering Cancer Center ) 5917 ( Other Identifier: CTEP ) P30CA008748 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 6, 2003 Key Record Dates |
| Results First Posted: | July 6, 2017 |
| Last Update Posted: | July 6, 2017 |
| Last Verified: | June 2017 |
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Stomach Neoplasms Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Deoxyglucose Alovudine Cisplatin Irinotecan |
Camptothecin Fluorodeoxyglucose F18 Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Radiopharmaceuticals Antineoplastic Agents, Phytogenic Antimetabolites Antiviral Agents Anti-Infective Agents |