Stomach and Gastro-Esophageal Junction (GEJ) CancerPhase 2NCT02251951
Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer
A Phase 2 study testing nab-Paclitaxel in people with Stomach and Gastro-Esophageal Junction (GEJ) Cancer, run by Hellenic Oncology Research Group at 6 sites in Greece.
Trial summary
The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and gastro-esophageal junction Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stomach and Gastro-Esophageal Junction (GEJ) Cancer
- What is being tested?
- nab-Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 6 sitesGreece
- Study dates
- Sep 2012to Jun 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old
- Disease progression after treatment with the DCF regimen
- Assessable target lesion(s) as defined by RECIST criteria
- ECOG performance status ≤ 1
- Estimated life expectancy more than 3 months
- Serum bilirubin less than 1.5 times the upper normal limit
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- Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit
- Creatinine Clearance ≥50 ml/min
- Neutrophil count more than 1.5x 109 /L
- Platelet count more than 100x 109 /L
- Hemoglobin more than 8g/dL
- Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations.
Who cannot join
- Gastrointestinal bleeding
- Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort
- CNS metastases
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
- Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
- Known hypersensitivity reaction to the component of the treatment
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- Active infection or malnutrition or bowel obstruction
- Legal incapacity or limited legal capacity
- Definite contraindications for the use of corticosteroids
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- Chronic inflammation of the bowel
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
- Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
- Second primary tumor other than non-melanoma skin cancer or in situ cervical cancer
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Greece6 sites
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
Air Forces Military Hospital of Athens Athens, Greece
Athens
SOTIRIA Hospital, Medical Oncology Department
Athens
"Ag. Georgios" General Hospital of Chania
Chania
University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece
Heraklion, Crete
"PAPAGEORGIOY" General Hospital of Thessaloniki
Thessaloniki
About this study
Official title: A Multicenter, Phase II, Single-Arm Clinical Trial of Nab-Paclitaxel as Salvage Treatment for Patients With Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal Junction.
The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and gastro-esophageal junction
Read the detailed description
Adenocarcinomas of the stomach or gastrointestinal junction refractory/resistant to 1st line chemotherapy are considered as an orphan disease with limited (if any) treatment options. The promising results of Nab-Paclitaxel derived from preclinical studies and from clinical trials conducted in breast cancer patients open the field to develop such therapeutic approaches in other cancers types usually treated with taxanes such as gastric and GEJ adenocarcinomas. We design a phase II study in order to evaluate the effect of nab-Paclitaxel as salvage treatment for patients with advanced cancer of the stomach and GEJ previously treated with the DCF regimen.
- Being tested
- nab-Paclitaxel
- Keywords
- Cancer, Stomach, Gastro-Esophageal Junction, Salvage treatment, Nab-paclitaxel
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-PaclitaxelDrug
Also called Abraxane
Abraxane: 150mg/m2 i.v weekly for 3 consecutive weeks followed by a week of rest (28d)
| Study group | Role | What they receive |
|---|---|---|
| nab-Paclitaxel | Experimental | Abraxane Receives: Drug: nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Documented response rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response
Measured: Disease evaluation every 8 weeks up to 108 weeks
Secondary outcomes (4)
Disease control rate
Documented disease control rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response
Measured: Disease evaluation every 8 weeks up to 108 weeks
Progression Free Survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 108 weeks
Measured: Up to 108 weeks
Overall Survival
From date of randomization until the date of last follow up or death from any cause, assessed up to 108 weeks
Measured: Up to 108 weeks
Number of Participants with Adverse Events
Measured: Every two weeks up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startSep 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach and Gastro-Esophageal Junction (GEJ) CancerStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Souglakos, MD, Principal investigator, University Hospital of HerklionVassilis Georgoulias, MD, Principal investigator, University Hospital of Heraklion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251951
- Sponsor's protocol ID
- CT/12.05
- Status last verified
- Oct 2015
- First submitted
- 5 Jul 2014
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase II, Single-Arm Clinical Trial of Nab-Paclitaxel as Salvage Treatment for Patients With Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal Junction.
- ClinicalTrials.gov ID
- NCT02251951
- Acronym / sponsor ID
- CT/12.05
- Keywords
- Cancer, Stomach, Gastro-Esophageal Junction, Salvage treatment, Nab-paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Sep 2014 (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.
The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and gastro-esophageal junction
Detailed description
Adenocarcinomas of the stomach or gastrointestinal junction refractory/resistant to 1st line chemotherapy are considered as an orphan disease with limited (if any) treatment options. The promising results of Nab-Paclitaxel derived from preclinical studies and from clinical trials conducted in breast cancer patients open the field to develop such therapeutic approaches in other cancers types usually treated with taxanes such as gastric and GEJ adenocarcinomas. We design a phase II study in order to evaluate the effect of nab-Paclitaxel as salvage treatment for patients with advanced cancer of the stomach and GEJ previously treated with the DCF regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab-Paclitaxel | Experimental | Drug: nab-PaclitaxelAbraxane |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age >18 years old
- Disease progression after treatment with the DCF regimen
- Assessable target lesion(s) as defined by RECIST criteria
- ECOG performance status ≤ 1
- Estimated life expectancy more than 3 months
Key exclusion criteria (14 listed)
- Gastrointestinal bleeding
- Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort
- CNS metastases
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
- Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
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 |
|---|---|---|
| nab-PaclitaxelAlso: AbraxaneAbraxane: 150mg/m2 i.v weekly for 3 consecutive weeks followed by a week of rest (28d) | Drug | nab-Paclitaxel |
Primary outcome
Overall Response Rate
Time frame: Disease evaluation every 8 weeks up to 108 weeks
Documented response rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response
4 secondary outcomes
Disease control rate
Time frame: Disease evaluation every 8 weeks up to 108 weeks
Progression Free Survival
Time frame: Up to 108 weeks
Overall Survival
Time frame: Up to 108 weeks
Number of Participants with Adverse Events
Time frame: Every two weeks up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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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.
John Souglakos, MD principal investigator
University Hospital of Herklion
Vassilis Georgoulias, MD principal investigator
University Hospital of Heraklion
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nab-Paclitaxel in people with Stomach and Gastro-Esophageal Junction (GEJ) Cancer, run by Hellenic Oncology Research Group at 6 sites in Greece.
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 12 inclusion and 14 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 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Greece. 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?
Overall Response Rate (time frame: Disease evaluation every 8 weeks up to 108 weeks). 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 8 Oct 2015.