- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00087503
Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy
March 27, 2008 updated by: Pfizer
A Phase II Efficacy And Safety Study Intravenous Edotecarin In Patients With Advanced Gastric Cancer That Has Progressed Or Recurred After Prior Fluropyrimidine-Based Chemotherapy
This will be an international, multicenter, uncontrolled, 2-stage, phase II study in adult patients with advanced gastric cancer, reasonable performance status, good organ function, lack of serious concomitant medical conditions.
Patients must have progressed or recurred after a fluoropyrimidine-containing regimen at anytime for primary metastatic disease or within 6 months of last dose of adjuvant therapy.
Twenty-one evaluable patients will be enrolled in Stage 1.
If at least 2 objective tumor responses are observed in the first 21 evaluable patients, the study will be expanded to enroll a total of 41 evaluable patients.
Edotecarin will be administered at a starting dose of 13 mg/m2 as an IV infusion over 60 minutes in repeated 3-week cycles treatment.
Study Overview
Study Type
Interventional
Enrollment
28
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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- Pfizer Investigational Site
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Bruxelles, Belgium
- Pfizer Investigational Site
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Gent, Belgium
- Pfizer Investigational Site
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Leuven, Belgium
- Pfizer Investigational Site
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Lille, France
- Pfizer Investigational Site
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Barcelona, Spain
- Pfizer Investigational Site
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Madrid, Spain
- Pfizer Investigational Site
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Kaohsiung, Taiwan
- Pfizer Investigational Site
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Kwei-Shan, Taiwan
- Pfizer Investigational Site
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Birmingham, United Kingdom
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (i.e., an adenocarcinoma with >50% extension in the stomach)
- Presence of locally advanced or metastatic disease non-amenable to surgery +/- chemo-radiation with curative intent
- Progression or recurrence after a fluoropyrimidine-containing regimen at any time for primary metastatic disease or within 6 months of last dose of adjuvant therapy
- Presence of at least 1 measurable (target) lesion. Target lesions are defined as those lesions that can be measured in at least 1 dimension as >=20mm with conventional techniques or >=10mm with spiral computerized tomography (CT) scan. Previously irradiated lesions will not be considered as target lesions.
- All previous therapies must have been discontinued at least 4 weeks before study entry, and all acute toxic effects (excluding alopecia or neurotoxicity) of any prior therapy must have resolved to NCI CTC (Version 2.0) Grade <=1 (please see inclusion criteria #8 below for exceptions)
- Age >= 18 years
- ECOG performance status of 0, 1 or 2
- Baseline tests within the following limits: Absolute neutrophil count (ANC) >= 1500/mm3 (1.5 x 10(9)/L) Platelets >= 100,000/mm3 (100 x 10(9)/L) Hemoglobin >= 9.0 g/dL Serum creatinine <= 1.5 mg/dl (or <= 133 mmol/L) Total serum bilirubin <= 1.5 x upper limits of normal (ULN) regardless of liver involvement secondary to tumor SGOT <= 2.5 x ULN; <=5 x ULN if there is liver involvement secondary to tumor Albumin >=3.0 g/dL Pregnancy test for females of childbearing potential is negative within 7 days of starting treatment
- Evidence of personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion Criteria:
- Prior treatment with another topoisomerase I inhibitor
- More than 1 prior chemotherapy regimen for advanced disease
- Prior radiation therapy to >25% of the bone marrow
- Any investigational agent received in the 4 weeks before enrollment to this study and/or current enrollment in another therapeutic clinical trial
- Previous high-dose chemotherapy requiring hematopoietic stem cell rescue
- Known brain metastases, or spinal cord compression, or carcinomatous meningitis (baseline CT or magnetic resonance imaging (MRI) scan of the brain required only in case of clinical suspicion of central nervous system metastases)
- Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri
- Active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea
- Any of the following in the past 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event
- Ongoing cardiac dysrhythmias of NCI CTC grade >=2, atrial fibrillation of any grade
- Active infection, including known human immunodeficiency virus (HIV) positivity
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study
- Pregnancy or breast-feeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. Fertile patients who are refusing to use reliable contraceptive methods
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To assess the antitumor activity of edotecarin by repeating radiographic assessments at 6-week intervals for all patients.
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Secondary Outcome Measures
Outcome Measure |
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To determine the time of onset and duration of tumor control, and overall survival.
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In addition, the safety and tolerability profile of edotecarin will be assessed, and plasma pharmacokinetic (PK) profile of edotecarin will be evaluated.
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Blood samples for PK evaluation will be collected during Cycles 1 and 2 and limited to the patients included in the first stage of the study.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
July 9, 2004
First Submitted That Met QC Criteria
July 12, 2004
First Posted (Estimate)
July 13, 2004
Study Record Updates
Last Update Posted (Estimate)
April 1, 2008
Last Update Submitted That Met QC Criteria
March 27, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EDOAGA-6736-001
- A5921008
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.
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