Metastatic Gastric CancerPhase 2B-DOCTNCT01359397
Docetaxel, Oxaliplatin, Capecitabine, Bevacizumab and Trastuzumab in Patients With Locally Advanced or Metastatic Gastric Cancer
A Phase 2 study testing Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab and Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab in people with Metastatic Gastric Cancer and Adenocarcinoma of the Gastro-oesophageal Junction, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Gastric Cancer, Adenocarcinoma of the Gastro-oesophageal Junction
- What is being tested?
- Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab and Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteNetherlands
- Study dates
- Mar 2011to May 2015
- 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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- History or clinical evidence of brain metastases.
- Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
- Positive serum pregnancy test in women of childbearing potential.
- Subjects with reproductive potential not willing to use an effective method of contraception.
- Any investigational drug treatment within 4 weeks of start of study treatment.
- Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastastic site peripherally and patient recovered from any acute toxicity)
- Arterial thrombosis; cerebrovascular accident within 6 months prior to study enrolment.
- Therapeutic use of oral coumarin-derived or LMWH anticoagulants or NSAIDs.
- Continuous use of immunosuppressive agents (for the use of corticosteroids see also #12).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Docetaxel, Oxaliplatin, Capecitabine With Bevacizumab and Trastuzumab in Case of Human Epidermal Growth Factor Receptor 2 (HER2)-Positivity in Patients With Locally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal Junction (B-DOCT Study)
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.
- Being tested
- Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab
- Keywords
- Adenoca. stomach/gastr. Junct.
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel, Oxaliplatin, Capecitabin, BevacizumabDrug
Her2 - patients only
Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, TrastuzumabDrug
for Her2 + patients only
| Study group | Role | What they receive |
|---|---|---|
| Herceptin - | Active comparator | Not described Receives: Drug: Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab |
| Herceptin + | Experimental | Not described Receives: Drug: Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
the time measured from the day of registration to first progression or death
Measured: 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
Toxicity will be evaluated during/after every course. Patients having received ≥1 treatment doses are evaluable for toxicity. Evaluation will be performed on the safety population (having received treatment). Clinical and laboratory toxicity will be graded according to NCI common toxicity criteria, version 4.0.
Measured: Patients will be followed for an average period of 1 year
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Gastric CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359397
- Sponsor's protocol ID
- M10B-DOCT
- Other IDs
- 2010-022699-30
- Acronym
- B-DOCT
- Status last verified
- Jan 2021
- First submitted
- 17 May 2011
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Docetaxel, Oxaliplatin, Capecitabine With Bevacizumab and Trastuzumab in Case of Human Epidermal Growth Factor Receptor 2 (HER2)-Positivity in Patients With Locally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal Junction (B-DOCT Study)
- ClinicalTrials.gov ID
- NCT01359397
- Acronym / sponsor ID
- B-DOCT / M10B-DOCT
- Keywords
- Adenoca. stomach/gastr. Junct.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2015 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herceptin - | Active comparator | Drug: Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab |
| Herceptin + | Experimental | Drug: Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel, Oxaliplatin, Capecitabin, BevacizumabHer2 - patients only | Drug | Herceptin - |
| Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumabfor Her2 + patients only | Drug | Herceptin + |
Primary outcome
Progression free survival
Time frame: Patients will be followed for an average period of 1 year
the time measured from the day of registration to first progression or death
2 secondary outcomes
Number of Participants with Serious Adverse Events as a Measure of Safety and Tolerability
Time frame: Patients will be followed for an average period of 1 year
Overall survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab and Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab in people with Metastatic Gastric Cancer and Adenocarcinoma of the Gastro-oesophageal Junction, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 9 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 27 Jan 2021. 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 Netherlands. 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?
Results are not available in the source record.
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?
Progression free survival (time frame: Patients will be followed for an average period of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2021.