AzTrials
AzTrials

Advanced Gastric CancerPhase 1/2NCT00845884

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

A Phase 1/2 study testing Docetaxel, Cisplatin, Capecitabine, Bevacizumab in people with Advanced Gastric Cancer, run by Rabin Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Advanced Gastric Cancer
What is being tested?
Docetaxel, Cisplatin, Capecitabine, Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteIsrael
Study dates
Feb 2009to Dec 2012
Phase
Phase 1/2
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 24Show fewer
  • 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.
  • -

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Davidoff Cancer Center, Rabin Medical Center

    Petah Tikva, 49100

    Baruch Brenner, MD, 972-3-9378005, brennerb@clalit.org.il

    Baruch Brenner, MD

Other trials in Israel

About this study

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

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.

Being tested
Docetaxel, Cisplatin, Capecitabine, Bevacizumab
Keywords
Gastric, Cancer, Advanced, Docetaxel, Cisplatin, Capecitabine, Bevacizumab
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docetaxel, Cisplatin, Capecitabine, BevacizumabDrug

    Also called Taxotere (Docetaxel), Cisplatin, Xeloda (Capecitabine), Avastin (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.
Study groups in NCT00845884
Study groupRoleWhat they receive
AVDCFExperimentalDrug: Docetaxel, Cisplatin, Capecitabine, Bevacizumab
Receives: Drug: Docetaxel, Cisplatin, Capecitabine, Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. response rate

    Measured: 2/2009-12/2012

Secondary outcomes (1)

  1. Safety, PFS, overall survival

    Measured: 2/2009-12/2012

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionDec 2012 (estimated)
  4. Study completionDec 2012 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00845884
Sponsor's protocol ID
AVDCF-2008
Status last verified
Feb 2009
First submitted
16 Feb 2009
Last updated
18 Feb 2009
Results posted
No
Data monitoring committee
No

Publications

  • Brenner B, Sarfaty M, Purim O, Kundel Y, Amit L, Abramovich A, Sadeh Gonik U, Idelevich E, Gordon N, Medalia G, Sulkes A. A Phase Ib/II Study Evaluating the Combination of Weekly Docetaxel and Cisplatin Together with Capecitabine and Bevacizumab in Patients with Advanced Esophago-Gastric Cancer. PLoS One. 2016 Jul 8;11(7):e0157548. doi: 10.1371/journal.pone.0157548. eCollection 2016.

    PubMed 27390847

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Docetaxel, Cisplatin, Capecitabine, Bevacizumab in people with Advanced Gastric Cancer, run by Rabin Medical Center at 1 site in Israel.

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 7 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

response rate (time frame: 2/2009-12/2012). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00845884, which also lists 1 linked publication.

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 18 Feb 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in