- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00061932
Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach
A Phase II Study of PS-341 Alone or in Combination With Irinotecan in Patients With Adenocarcinoma of the Gastroesophageal Junction (GEJ) or Stomach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the response rate for the combination of irinotecan and PS 341 in patients with previously untreated adenocarcinoma of the stomach or GEJ.
II. To determine the response rate for PS341 in patients with previously treated adenocarcinoma of the stomach or GEJ.
III. To determine the toxicities and recovery from toxicities for patients receiving PS 341 alone or in combination with irinotecan IV. To perform GeneChip analysis on biopsy specimens prior to and subsequent to treatment with PS341 to determine changes in patterns of gene expression
OUTLINE: Patients are stratified (stratum 2 closed to accrual as of 9/19/2006) according to prior chemotherapy for advanced disease (yes vs no).
STRATUM 1 (Previously untreated patients): Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.
STRATUM 2 (Previously treated patients) (closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
In both strata, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10467-2490
- Montefiore Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed adenocarcinoma of the GE junction or stomach, which is beyond the scope of surgical resection
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan
Patients may have received adjuvant therapy for resected disease
- Patients who have received no prior systemic therapy for advanced disease are eligible to receive PS341 + irinotecan
- Patients are eligible for PS-341 as a single agent if they have received any number of prior regimens for gastric cancer
- Life expectancy of greater than 6 weeks
- ECOG performance status =< 2 (Karnofsky >= 60%)
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >=100,000/uL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
- Creatinine within normal institutional limits
- When possible, patients will undergo an esophagogastroduodenoscopy (EGD) with biopsy prior to therapy then at 24 hours after starting PS-341
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents, concurrent radiation therapy, or other chemotherapy; patients who have had photodynamic therapy either within 4 weeks of study entry or concurrently are ineligible, unless it was used to relieve esophageal obstruction that could not be treated with laser, stent or dilatation
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to PS 341 or other agents used in the study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with PS341
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study
- Patients with a concurrent malignancy are excluded (except for early stage squamous cell carcinoma of the skin or cervix which can be treated locally); patients with an advanced malignancy within the past five years are not eligible; patients with a prior malignancy who have been disease free for five years are eligible
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stratum 1 (previously untreated)
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.
|
Given IV
Other Names:
Given IV
Other Names:
|
Experimental: Stratum 2 (previously treated)
(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
|
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
True Response Rate Evaluated for the Combination of Irinotecan and PS341 by Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Up to 6 years
|
CT or MRI imaging scans of measurable lesions were obtained at baseline and every 8 weeks thereafter.
Responses were classified according to RECIST criteria (version 1.0)
|
Up to 6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patterns of Gene Expression Pre- and Post-treatment Performed by GeneChip Analysis
Time Frame: Baseline to 6 years
|
Number of Participants with a Change in Gene Expression from Pre to Post Treatment
|
Baseline to 6 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Allyson Ocean, Montefiore Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Stomach Neoplasms
- Adenocarcinoma
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
- Bortezomib
Other Study ID Numbers
- NCI-2012-03015
- N01CM62204 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adenocarcinoma of the Gastroesophageal Junction
-
Accelerated Community Oncology Research NetworkAmgenTerminatedGastroesophageal Adenocarcinoma | Adenocarcinomas of the Gastroesophageal Junction | Adenocarcinoma of the Distal Esophagus | Adenocarcinoma of the Proximal StomachUnited States
-
UNICANCERBayerTerminatedAdenocarcinoma of the Gastroesophageal Junction | Adenocarcinoma of the StomachFrance
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingClinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Unresectable Gastroesophageal Junction Adenocarcinoma | Locally Advanced Gastroesophageal Junction Adenocarcinoma | Postneoadjuvant Therapy Stage III... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingEsophageal Adenocarcinoma | Esophageal Squamous Cell Carcinoma | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 | Pathologic Stage... and other conditionsUnited States
-
Milton S. Hershey Medical CenterCompletedPancreatic Adenocarcinoma | Gastric Adenocarcinoma | Adenocarcinoma of the Gastroesophageal JunctionUnited States
-
Medical University of LublinUnknownAdenocarcinoma of the Gastroesophageal JunctionPoland
-
University of Colorado, DenverNational Cancer Institute (NCI)RecruitingAdenocarcinoma of the Gastroesophageal Junction | Adenocarcinoma EsophagusUnited States
-
P. C. Thuss-PatienceRecruitingGastroesophageal Junction Adenocarcinoma | Adenocarcinoma of the StomachGermany
-
Institut für Klinische Krebsforschung IKF GmbH...CompletedGastric Adenocarcinoma | Metastatic Adenocarcinoma of the Gastroesophageal JunctionGermany
-
H. Lee Moffitt Cancer Center and Research InstituteAventis PharmaceuticalsTerminatedEsophageal Adenocarcinomas | Adenocarcinomas of the Gastroesophageal JunctionUnited States
Clinical Trials on bortezomib
-
The First Affiliated Hospital of Soochow UniversityUnknownMultiple Myeloma Proved by Laboratory TestsChina
-
Baylor College of MedicineMillennium Pharmaceuticals, Inc.CompletedProstate NeoplasmsUnited States
-
NCIC Clinical Trials GroupCompleted
-
University Hospital, Clermont-FerrandLaboratoires TakedaUnknownMultiple Myeloma | Adult | Bortezomib RegimenFrance
-
Janssen-Cilag International NVCompletedMultiple MyelomaTurkey, Greece, Czech Republic, Austria, Germany, Sweden, United Kingdom, Denmark
-
University Health Network, TorontoNational Cancer Institute (NCI)CompletedBladder Cancer | Transitional Cell Cancer of the Renal Pelvis and UreterUnited States, Canada
-
Southwest Oncology GroupNational Cancer Institute (NCI)Completed
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedLymphoma | Myelodysplastic Syndromes | Leukemia | Multiple Myeloma and Plasma Cell NeoplasmUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Completed
-
NYU Langone HealthNational Cancer Institute (NCI)CompletedLymphoma | Small Intestine Cancer | Unspecified Adult Solid Tumor, Protocol SpecificUnited States