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Gastric CancerPhase 2NCT00952003

Oxaliplatin/Irinotecan/Bevacizumab Followed by Docetaxel/Bevacizumab in Inoperable Locally Advanced or Metastatic Gastric Cancer Patients

A Phase 2 study testing Oxaliplatin, Irinotecan, Bevacizumab, Docetaxel in people with Gastric Cancer and Unresectable, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 7 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to determine the efficacy of an Oxaliplatin / Irinotecan / Bevacizumab therapy followed by Docetaxel / Bevacizumab therapy followed by Bevacizumab until progression in the treatment of locally advanced metastatic gastric cancer, in terms of response rates (complete or partial… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Unresectable
What is being tested?
Oxaliplatin, Irinotecan, Bevacizumab, Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
7 sitesAustria
Study dates
Jul 2009to Jun 2020
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

  • Signed informed consent
  • Histologically proven gastric adenocarcinoma
  • Measurable or evaluable, inoperable locally advanced or metastatic disease. Presence of at least one measurable lesion according to RECIST criteria.
  • No previous palliative chemotherapy and/or immunotherapy
  • Life expectancy of more than 3 months
  • Age ≥ 18 years.
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  • ECOG performance status 0 - 2
  • Ability to understand and comply with requirements of study protocol and trial participation
  • Patients of either sex are eligible for study entry. Women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception (e.g. intrauterine device (IUD), birth control pills, or barrier device) beginning 2 weeks prior to first dose of study drug until 6 months after the final dose of study drug.
  • Hematological status:
  • Leucocytes ≥ 3 x 109/l Platelets ≥ 100 x 109/l •Renal function: Serum creatinine: ≤ 1.5 x upper normal limit of normal (ULN)
  • •Hepatic function: AST and ALT: < 2.5 x ULN or < 5 x ULN if hepatic metastases are present Alkaline phosphatase: < 2.5 x ULN or < 5 x ULN if hepatic metastases are present Total bilirubin level ≤ 1.5 x ULN
  • Patient must have an INR ≤ 1.5 and aPTT ≤ 1.5 x ULN within 7 days prior to randomisation
  • Baseline evaluations performed before treatment start: clinical and blood evaluations no more than 7 days prior to planned first course; tumoral assessment (CT scan or MRI) no more than 4 weeks prior to planned first course

Who cannot join

  • Pregnant or lactating women.
  • Women of child-bearing potential and men not using effective contraception.
  • Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy) or
  • Neo/Adjuvant treatment with Irinotecan and/or docetaxel and/or Bevacizumab
  • Patients with locally advanced disease who are candidates for curative therapy (including operation and/or chemotherapy and/or radiotherapy).
  • Prior history of chronic enteropathy, chronic diarrhea, unresolved bowel obstruction/ subobstruction, or extensive abdominopelvic radiation therapy.
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  • Previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix.
  • Evidence of CNS metastasis at baseline. A CT or MRI scan within 28 days prior to randomisation is mandatory to exclude CNS involvement in case of clinical suspicion of CNS metastasis.
  • Peripheral neuropathy (NCI CTC grade ≥ 1).
  • Inadequate renal function:
  • adequate renal function:ould be ≥ 60 mL/min. The Cockroft and Gault formula is recommended for calculation of creatinine clearance. Patients with a creatinine clearance just below 60 ml/min may be eligible if a measured creatinine clearance (based on 24 hour urine collection or other reliable method) is ≥ 60 mL/min.
  • Urine dipstick for proteinuria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr.
  • Serious medical or psychiatric disorders that would interfere with the patient's informed consent or compliance with the requirements of the protocol or that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
  • Active bacterial, viral or fungal infection (including acute or chronic-active infection with HBV or HCV).
  • Acute intra abdominal inflammatory process.
  • Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents (≤ 6 months prior to randomisation), myocardial infarction (≤ 6 months prior to randomisation), unstable angina, New York Heart Association Grade II or greater congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment.
  • Prior history of hypertensive crisis or hypertensive encephalopathy.
  • Evidence of tumour invading major blood vessels on imaging. The investigator or the local radiologist must exclude evidence of tumour that is fully contiguous with, surrounding, or extending into the lumen of a major blood vessel (e.g. pulmonary artery or superior vena cava).
  • Serious uncontrolled coagulation disorder or thrombo-embolic complications (history of embolisms or thromboses) within 6 months prior to study start or history of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
  • Major surgical procedures within 4 weeks prior to study entry or planned major surgical procedures throughout the course of the study. Patients must have fully recovered from any surgical procedures conducted prior to 4 weeks before study entry.
  • Minor surgery, including insertion of an indwelling catheter, within 48 hours prior to the first bevacizumab infusion.
  • Concurrent or recent (within 10 days) anticoagulant therapy. Prophylactic use of anticoagulants is allowed.
  • Chronic daily treatment with aspirin (> 325 mg/day) or clopidogrel (> 75 mg/day).
  • Chronic daily treatment with oral corticosteroids (dose of > 10 mg/day methylprednisolone equivalent). Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed.
  • Known history of Deep Vein Thrombosis (DVT) and/ or pulmonary embolism (PE).
  • Non-healing wound, active peptic ulcer or bone fracture.
  • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment or active gastrointestinal bleeding.
  • Concurrent treatment with an investigational drug or participation in another clinical trial.
  • Contraindications for the study regimen or known hypersensitivity to the study drugs or to Chinese hamster ovary cell products or to other recombinant human or humanised antibodies.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Austria7 sites

  • Universitätsklinik Innsbruck

    Innsbruck, A-6020

  • A.ö. Landeskrankenhaus Leoben

    Leoben, A-8700

  • Krankenhaus der Stadt Linz

    Linz, A-4020

  • Universitaetsklinik f. Innere Medizin III

    Salzburg, A-5020

  • Universitätsklinik Wien

    Vienna, 1090

  • Klinikum Wels-Grieskirchen GmbH

    Wels, A-4600

  • BKH Zams

    Zams, A-6511

Other trials in Austria

About this study

Official title: Phase II Study of Oxaliplatin / Irinotecan / Bevacizumab Followed by Docetaxel / Bevacizumab in Inoperable Locally Advanced or Metastatic Gastric Cancer Patients

The primary objective of this study is to determine the efficacy of an Oxaliplatin / Irinotecan / Bevacizumab therapy followed by Docetaxel / Bevacizumab therapy followed by Bevacizumab until progression in the treatment of locally advanced metastatic gastric cancer, in terms of response rates (complete or partial response, determined by radiologic evaluation according to Response Evaluation Criteria in Solid Tumors (RECIST)).

Secondary objectives Secondary Objective: To determine the safety profile of a an Oxaliplatin/Irinotecan/Bevacizumab therapy followed by Docetaxel/Bevacizumab therapy followed by Bevacizumab until progression in terms of qualitative and quantitative toxicities from first study treatment dose until completion of study treatment due to progression or for any other reason.

Secondary Objective: To evaluate the study population with respect to the following: overall survival (from treatment start until death from any cause) and progression free survival (from treatment start until progression or death from any cause).

Read the detailed description

This is a non-randomized, multicenter, open-label, single-arm Phase II study in patients with inoperable histologically proven inoperable locally advanced or metastatic gastric cancer. Eligible patients must be therapy naïve and have received no previous chemotherapy or immune therapy for their inoperable gastric cancer. Neo/Adjuvant Chemotherapy or adjuvant Chemo/Radiotherapy are allowed. A total of 40 evaluable patients will be recruited and evaluated for efficacy and safety of a sequential chemoimmunotherapy combination regime.

Overall Study Design:

Eligible patients will receive Oxaliplatin, Irinotecan and Bevacizumab for 3 cycles followed by Docetaxel and Bevacizumab for a further 3 cycles. Upon completion of the combination therapy cycles Bevacizumab will be continued until progression. Safety assessments will be conducted in 4-weekly intervals; efficacy assessments will be conducted at 12 weekly intervals, at completion of every third treatment cycle.

This study is expected to start in Q1 2009. The last patient is expected to enter the study in Q2 2010, following an 18 month recruitment period. Taking into account treatment duration the study is expected to end in Q4 2010. Study end will be at Last Subject Last Visit at Final Staging upon disease progression. Follow-up after Last Subject Last Visit will be conducted according to local standard of care thereafter, and is not part of study procedures.

Being tested
Oxaliplatin, Irinotecan, Bevacizumab, Docetaxel
Keywords
Avastin, Campto, Oxaliplatin, Taxotere
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Oxaliplatin, Irinotecan, Bevacizumab, DocetaxelDrug

Study groups in NCT00952003
Study groupRoleWhat they receive
interventional armExperimentalOxaliplatin, Irinotecan and Bevacizumab for 3 cycles followed by Docetaxel and Bevacizumab for a further 3 cycles. Upon completion of the combination therapy cycles Bevacizumab will be continued until progression.
Receives: Drug: Oxaliplatin, Irinotecan, Bevacizumab, Docetaxel

What is being measured

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

  1. To determine efficacy in terms of response rate according to RECIST criteria

    Measured: 3-6 months

Secondary outcomes (3)

  1. Safety of treatment

    Measured: 3-6 months

  2. To determine median progression-free survival times following treatment with a chemoimmune therapy

    Measured: 3 - 6 months

  3. To determine overall survival time following treatment with a chemoimmune therapy

    Measured: 3 - 6 months

Timeline

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

  1. First posted4 Aug 2009 (estimated)
  2. Study startJul 2009
  3. Primary completion22 Oct 2014
  4. Study completionJun 2020

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00952003
Sponsor's protocol ID
AGMT GASTRIC-3
Status last verified
Nov 2020
First submitted
3 Aug 2009
Last updated
30 Nov 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin, Irinotecan, Bevacizumab, Docetaxel in people with Gastric Cancer and Unresectable, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 7 sites in Austria.

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 14 inclusion and 29 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 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Austria. 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 determine efficacy in terms of response rate according to RECIST criteria (time frame: 3-6 months). 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 NCT00952003.

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 30 Nov 2020.

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