Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy
NCT00087503
ABOUT THIS STUDY
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Stomach Neoplasms | |||
Intervention ICMJE | Drug: Edotecarin | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 28 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | June 2005 | |||
Actual Primary Completion Date | June 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, France, Spain, Taiwan, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00087503 | |||
Other Study ID Numbers ICMJE | EDOAGA-6736-001 A5921008 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |