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

NCT00952003 | Completed Phase 2

• 1 other identifier: AGMT GASTRIC-3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief 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 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).

Conditions

Gastric Cancer; Unresectable

Keywords

Avastin; Campto; Oxaliplatin; Taxotere

Outcome Measures

Primary Outcomes (1)

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

  3-6 months

Secondary Outcomes (3)

• Safety of treatment

  3-6 months

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

  3 - 6 months

• To determine overall survival time following treatment with a chemoimmune therapy

  3 - 6 months

Study Arms (1)

interventional arm

EXPERIMENTAL

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.

Drug: Oxaliplatin, Irinotecan, Bevacizumab, Docetaxel

Interventions

Oxaliplatin, Irinotecan, Bevacizumab, Docetaxel DRUG

interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Arbeitsgemeinschaft medikamentoese Tumortherapie: lead
• Pfizer: collaborator
• Sanofi: collaborator
• Roche Pharma AG: collaborator

Study Sites (7)

Universitätsklinik Innsbruck

Innsbruck, A-6020, Austria

Location

A.ö. Landeskrankenhaus Leoben

Leoben, A-8700, Austria

Location

Krankenhaus der Stadt Linz

Linz, A-4020, Austria

Location

Universitaetsklinik f. Innere Medizin III

Salzburg, A-5020, Austria

Location

Universitätsklinik Wien

Vienna, 1090, Austria

Location

Klinikum Wels-Grieskirchen GmbH

Wels, A-4600, Austria

Location

BKH Zams

Zams, A-6511, Austria

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Irinotecan; Bevacizumab; Docetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Richard Greil, Prof.Dr.

  AGMT Arbeitsgemeinschaft Medikamentöse Tumortherpie gemeinnützige GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 4, 2009
• Study Start: July 1, 2009
• Primary Completion: October 22, 2014
• Study Completion: June 1, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

AU (7)