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Phase I/II Study of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in Advanced Gastric Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845884
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rabin Medical Center
  Purpose
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.

Condition Intervention Phase
Advanced Gastric Cancer Drug: Docetaxel, Cisplatin, Capecitabine, Bevacizumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study Evaluating the Combination of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in Patients With Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • response rate [ Time Frame: 2/2009-12/2012 ]

Secondary Outcome Measures:
  • Safety, PFS, overall survival [ Time Frame: 2/2009-12/2012 ]

Estimated Enrollment: 49
Study Start Date: February 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVDCF
Drug: Docetaxel, Cisplatin, Capecitabine, Bevacizumab
Drug: Docetaxel, Cisplatin, Capecitabine, Bevacizumab
  • Docetaxel 30-35 mg/m2 IV, on Days 1 and 8, Q:21 days.
  • Cisplatin 30-35 mg/m2 IV, on Days 1 and 8, Q:21 days.
  • Capecitabine 1,600 mg/m2/d PO, divided into two daily doses, on Days 1-14, Q:21 days.
  • Bevacizumab 7.5 mg/kg IV, on Day 1, Q:21 days.
Other Names:
  • Taxotere (Docetaxel)
  • Cisplatin
  • Xeloda (Capecitabine)
  • Avastin (Bevacizumab

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients above 18 years of age at the time of enrollment.
  2. Histologically confirmed previously untreated metastatic or unresectable adenocarcinoma of the stomach.
  3. Patients must have at least one measurable lesion (measuring >10mm in standard CT or >5mm in spiral CT).
  4. Adequate organ function.
  5. Life expectancy of at least three months.
  6. Patients must have an ECOG Performance Status of 0 or 1.
  7. Signed written informed consent to participate in the study.

Exclusion Criteria:

  1. Participation in an investigational trial within 30 days of the screening visit.
  2. Known allergy or any other adverse reaction to any of the study drugs or to any related compound.
  3. 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.
  4. Prior treatment with drugs included in the investigational regimen. Prior use of 5-fluorouracil in the adjuvant setting is allowed.
  5. Significant bleeding by the primary tumor (in unoperated patients).
  6. 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.
  7. 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.
  8. Severe co-morbid conditions including uncontrolled diabetes or hypertension, cerebral vascular disease or uncontrolled infection.
  9. 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
  10. For women of child-bearing potential: a positive pregnancy test at screening or breast-feeding.
  11. 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.
  12. Clinically significant hearing loss.
  13. Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
  14. Known peripheral neuropathy of CTCAE v 3.0 Grade 1 or more.
  15. Organ allografts requiring immunosuppressive therapy.
  16. Serious, non-healing wound, ulcer, or bone fracture.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845884


Locations
Israel
Davidoff Cancer Center, Rabin Medical Center Not yet recruiting
Petach Tikva, Israel, 49100
Contact: Baruch Brenner, MD    972-3-9378005    brennerb@clalit.org.il   
Principal Investigator: Baruch Brenner, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Baruch Brenner, MD Davidoff Cancer Center, Rabin Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Baruch Brenner, MD, Davidoff Cancer Center, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00845884     History of Changes
Other Study ID Numbers: AVDCF-2008
First Submitted: February 16, 2009
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
Last Verified: February 2009

Keywords provided by Rabin Medical Center:
Gastric
Cancer
Advanced
Docetaxel
Cisplatin
Capecitabine
Bevacizumab

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Cisplatin
Bevacizumab
Capecitabine
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites