Docetaxel, Oxaliplatin, Capecitabine, Bevacizumab and Trastuzumab in Patients With Locally Advanced or Metastatic Gastric Cancer

NCT01359397 | Unknown Phase 2

• 2 other identifiers: M10B-DOCT2010-022699-30
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Background: It is estimated that in the Netherlands each year approximately 900 patients with gastric cancer or adenocarcinoma of the gastro-oesophageal junction are candidates for chemotherapy. Randomized studies comparing chemotherapy versus best supportive care have shown that survival and quality of life are prolonged with chemotherapy. However, no chemotherapy regimen is clearly superior with regard to prolongation of survival. Therefore, tolerability of treatment and ease of administration (outpatient compared to inpatient) are important considerations for the development of novel treatment schedules. Study design: This is an open-label, multicentre, phase II trial designed to evaluate the efficacy and safety of bevacizumab in combination with docetaxel, oxaliplatin and capecitabine chemotherapy (B-DOC) as first-line therapy in patients with inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. In case of HER2 positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction trastuzumab is added to this regimen (B-DOCT). Study Endpoints: Primary endpoint Progression free survival defined as the time measured from B-DOCT study, Protocol version 3.0 dated January 18, 2011 Page 5 / 60 the day of registration to first progression or death. Secondary endpoints Toxicity Overall survival, defined as the time from registration to death Response rate defined as the percentage of partial and complete responses Duration of response defined as time from response to first progression Translational research on pharmacogenomic and biological factors that may predict treatment response.

Conditions

Metastatic Gastric Cancer; Adenocarcinoma of the Gastro-oesophageal Junction

Keywords

Adenoca. stomach/gastr. Junct.

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  the time measured from the day of registration to first progression or death

  Patients will be followed for an average period of 1 year

Secondary Outcomes (2)

• Number of Participants with Serious Adverse Events as a Measure of Safety and Tolerability

  Patients will be followed for an average period of 1 year

• Overall survival

  12 months

Study Arms (2)

Herceptin -

ACTIVE COMPARATOR

Drug: Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab

Herceptin +

EXPERIMENTAL

Drug: Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab

Interventions

Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab DRUG

Her2 - patients only

Herceptin -

Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab DRUG

for Her2 + patients only

Herceptin +

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease not amenable to curative therapy.
• Measurable disease, according to the Response Evaluation Criteria in Solid Tumours (RECIST), assessed using imaging techniques (CT or MRI)
• ECOG Performance status 0, 1 or 2 (see Appendix 2)
• Life expectancy of at least 3 months
• Male or female age ≥ 18 years.
• Signed informed consent.
• Assessment of HER2 status (primary tumour or metastasis) by the central laboratory prior to initiation of study treatment (see section 9.1)
• Able to swallow and retain oral medication.
• LVEF ≥ 50% assessed by multigated radionucleotide angiography (MUGA) or cardiac ultrasound.

You may not qualify if:

• Any of the following will exclude the patient from the study:
• Previous chemotherapy for advanced/metastatic disease (prior peri-operative chemotherapy is allowed if at least 6 months has elapsed between completion of this therapy and enrolment into the study).
• Previous radiotherapy on the abdomen.
• Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
• Patients with active (significant or uncontrolled) gastrointestinal bleeding.
• Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity ≥ grade 2 NCI-CTCAE.
• Creatinin clearance \<50 mL/min.
• Neutrophil count \<1.5 × 109/L, or platelet count \<100 × 109/L.
• Serum bilirubin \>1.5 × upper limit of normal (ULN); or, AST or ALT \>2.5 × ULN (or \>5 × ULN in patients with liver metastases); or, alkaline phosphatase \>2.5 × ULN (or \>5 × ULN in patients with liver metastases, or \>10 × ULN in patients with bone but no liver metastases); or, albumin \<25 g/L.
• Known dihydropyrimidine dehydrogenase (DPD) deficiency.
• History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP \>180 mmHg or diastolic BP \>100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
• Patients with dyspnoea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
• Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
• Major surgery within 4 weeks of start of study treatment; serious or not healing wound.
• Known hypersensitivity to any of the study drugs, Chinese hamster ovary cell products or other murine or human recombinant antibodies.

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, Netherlands

Location

Related Links

• Related Info

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Oxaliplatin; Capecitabine; Bevacizumab; Trastuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2011
• First Posted: May 24, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2015
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

NL (1)