- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00845884
Phase I/II Study of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in Advanced Gastric Cancer
February 16, 2009 updated by: Rabin Medical Center
A Phase I/II Study Evaluating the Combination of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in Patients With Advanced Gastric Cancer
In spite of multiple attempts to improve the efficacy of first-line chemotherapy in advanced gastric cancer, the progress that has been achieved so far is rather limited, and many investigators are exploring newer regimens.A combination of decetaxel (Taxotere) with Cisplatin and 5-fluorouracil (5FU) is considered one of the most effective regimens in this disease.
However, it is associated with significant toxicity which avoided its general adaptation by the medical community.
The current study is exploring a newer way to administer these three drugs, hopefully making the regimen more comfortable, less toxic and maybe even more effective.
We will do this by changing the dose and timing of Taxotere and Cisplating, by replacing protracted infusion of 5FU with tablets of Capecitabine (Xeloda) and by adding the anti-angiogenic drug, Bevacizumab (Avastin), which had shown encouraging results in this disease.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
49
Phase
- Phase 2
- Phase 1
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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Petach Tikva, Israel, 49100
- Davidoff Cancer Center, Rabin Medical Center
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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
Male
Description
Inclusion Criteria:
- Patients above 18 years of age at the time of enrollment.
- Histologically confirmed previously untreated metastatic or unresectable adenocarcinoma of the stomach.
- Patients must have at least one measurable lesion (measuring >10mm in standard CT or >5mm in spiral CT).
- Adequate organ function.
- Life expectancy of at least three months.
- Patients must have an ECOG Performance Status of 0 or 1.
- Signed written informed consent to participate in the study.
Exclusion Criteria:
- Participation in an investigational trial within 30 days of the screening visit.
- Known allergy or any other adverse reaction to any of the study drugs or to any related compound.
- Prior anti-angiogenic treatment, chemotherapy or radiotherapy for advanced disease. Patients will be eligible if they had received adjuvant chemotherapy or radiotherapy more than 12 months prior to enrollment.
- Prior treatment with drugs included in the investigational regimen. Prior use of 5-fluorouracil in the adjuvant setting is allowed.
- Significant bleeding by the primary tumor (in unoperated patients).
Clinically significant (i.e. active) cardiovascular disease. This includes, but is not limited to, the following examples:
- Cerebrovascular accidents (up to 6 months prior to randomization)
- Myocardial infarction (up to 1 year prior to randomization).
- Uncontrolled hypertension (above 150/100 mmHg) while receiving chronic medication
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- Serious cardiac arrhythmia requiring medication.
- Clinically significant ECG findings. Patients who suffer from serious cardiac arrhythmia requiring medication can enter the study only if they are considered to be in a stable condition regarding both the arrhythmia and their medication. Patients with pacemakers are allowed to enter the study only if they are considered as being in a stable condition. In case of doubt, the investigator should obtain a consultation with a local cardiologist.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, not fully healed wounds, or anticipation of the need for major surgical procedure during the course of the study.
- Severe co-morbid conditions including uncontrolled diabetes or hypertension, cerebral vascular disease or uncontrolled infection.
- Fertile subjects who are not willing to use an acceptable method of contraception during the treatment period and for 28 days following completion of treatment
- For women of child-bearing potential: a positive pregnancy test at screening or breast-feeding.
- History of prior malignancy (other than non-melanoma skin cancer, in-situ cervical cancer, or superficial transitional cell bladder cancer) in the last 5 years prior to enrollment.
- Clinically significant hearing loss.
- Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
- Known peripheral neuropathy of CTCAE v 3.0 Grade 1 or more.
- Organ allografts requiring immunosuppressive therapy.
Serious, non-healing wound, ulcer, or bone fracture.
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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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AVDCF
Drug: Docetaxel, Cisplatin, Capecitabine, Bevacizumab
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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response rate
Time Frame: 2/2009-12/2012
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2/2009-12/2012
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety, PFS, overall survival
Time Frame: 2/2009-12/2012
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2/2009-12/2012
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Baruch Brenner, MD, Davidoff Cancer Center, Rabin Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
February 1, 2009
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
February 16, 2009
First Submitted That Met QC Criteria
February 16, 2009
First Posted (Estimate)
February 18, 2009
Study Record Updates
Last Update Posted (Estimate)
February 18, 2009
Last Update Submitted That Met QC Criteria
February 16, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Docetaxel
- Cisplatin
- Capecitabine
- Bevacizumab
Other Study ID Numbers
- AVDCF-2008
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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