Stomach NeoplasmsPhase 2NCT00087503
Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy
A Phase 2 study testing Edotecarin in people with Stomach Neoplasms, run by Pfizer at 10 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Edotecarin
- How many people
- 28 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Apr 2004to Jun 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Belgium3 sites
Pfizer Investigational Site
Brussels
Pfizer Investigational Site
Ghent
Pfizer Investigational Site
Leuven
Spain2 sites
Pfizer Investigational Site
Barcelona
Pfizer Investigational Site
Madrid
Taiwan2 sites
Pfizer Investigational Site
Kaohsiung City
Pfizer Investigational Site
Kwei-Shan
Location not given1 site
Pfizer Investigational Site
About this study
Official title: 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.
- Conditions
- Stomach Neoplasms
- Being tested
- Edotecarin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdotecarinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the antitumor activity of edotecarin by repeating radiographic assessments at 6-week intervals for all patients.
Secondary outcomes (3)
To determine the time of onset and duration of tumor control, and overall survival.
In addition, the safety and tolerability profile of edotecarin will be assessed, and plasma pharmacokinetic (PK) profile of edotecarin will be evaluated.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2004 (estimated)
- Study startApr 2004
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087503
- Sponsor's protocol ID
- EDOAGA-6736-001
- Other IDs
- A5921008
- Status last verified
- Mar 2008
- First submitted
- 9 Jul 2004
- Last updated
- 1 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00087503
- Acronym / sponsor ID
- EDOAGA-6736-001
- Conditions
- Stomach Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 13 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edotecarin | Drug | – |
Primary outcome
To assess the antitumor activity of edotecarin by repeating radiographic assessments at 6-week intervals for all patients.
3 secondary outcomes
To determine the time of onset and duration of tumor control, and overall survival.
In addition, the safety and tolerability profile of edotecarin will be assessed, and plasma pharmacokinetic (PK) profile of edotecarin will be evaluated.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Edotecarin in people with Stomach Neoplasms, run by Pfizer at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, Spain, Taiwan, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the antitumor activity of edotecarin by repeating radiographic assessments at 6-week intervals for all patients.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2008.