Study on the addition of Nab-paclitaxel (Abraxane) to capecitabine and oxaliplatin in the first-line treatment of metastastasized oesophagogastric carcinoma

A phase Ib/II study on the addition of Nab-paclitaxel (Abraxane) to capecitabine and oxaliplatin in the first-line treatment of metastastasized oesophagogastric carcinoma - ACTION

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001333-88-NL

Enrollment

154

Registered

2014-09-23

Start date

2014-10-16

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastasized oesophagogastric carcinoma

Interventions

Trade Name: Abraxane Pharmaceutical Form: Powder for dispersion for infusion INN or Proposed INN: PACLITAXEL CAS Number: 33069-62-4 Concentration unit: mg/m2 milligram(s)/square meter Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female = 18 year 2. Histological proof of metastastic or irresectable carcinoma of the stomach or oesophagus. 3. WHO 0-2. 4. Measureable disease as assessed by RECIST 1.1 5. Adequate bone marrow and organ function. 6. Informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54

Exclusion criteria

Exclusion criteria: 1. Prior systemic treatment for metastatic or irresectable stomach or oesophageal cancer 2. All target lesions in a radiation field without documented disease progressionn 3. WHO 3-4. 4. Use of other investigational drugs within 30 days of enrollment or 5 half-lives of the study drug, whichever is longer. 5. CNS metastases or a CNS malignancy. 6. Other previous malignancies except cervical carcinoma and squamous carcinoma of the skin = 5 years ago

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase 1: To assess the safety and tolerability of Nab-paclitaxel added to oxaliplatin and capecitabine at their currently optimal doses. Phase 2: To determine the anti-tumor activity of Nab-paclitaxel when co-administered with oxaliplatin and capecitabine in patients with irresectable or metastasized oesophagogastric cancer in terms of progression free survival. ;Secondary Objective: Phase 1: 1. To assess the number of complete cycles of Nab-paclitaxel, oxaliplatin and capecitabine delivered. 2. To assess response rate, progression free survival, overall survival. 3. To assess self-reported neurotoxicity. Phase 2: 1. To assess the number of complete cycles of Nab-paclitaxel, oxaliplatin and capecitabine delivered. 2. To assess response rate, overall survival. 3. To assess self-reported neurotoxicity.;Primary end point(s): Phase 1: (dose limiting toxicity) and MTD (maximum tolerated dose) of nab-paclitaxel co-administered with fixed doses of capecitabine and oxaliplatin in patients with metastatic or irresectable carcinoma of the stomach or oesophagus. Phase 2: Progression free survival;Timepoint(s) of evaluation of this end point: Phase 1: Continuously during treatment Phase 2: Every nine (9) weeks	—

Measure

Time frame

Main Objective: Phase 1: To assess the safety and tolerability of Nab-paclitaxel added to oxaliplatin and capecitabine at their currently optimal doses. Phase 2: To determine the anti-tumor activity of Nab-paclitaxel when co-administered with oxaliplatin and capecitabine in patients with irresectable or metastasized oesophagogastric cancer in terms of progression free survival. ;Secondary Objective: Phase 1: 1. To assess the number of complete cycles of Nab-paclitaxel, oxaliplatin and capecitabine delivered. 2. To assess response rate, progression free survival, overall survival. 3. To assess self-reported neurotoxicity. Phase 2: 1. To assess the number of complete cycles of Nab-paclitaxel, oxaliplatin and capecitabine delivered. 2. To assess response rate, overall survival. 3. To assess self-reported neurotoxicity.;Primary end point(s): Phase 1: (dose limiting toxicity) and MTD (maximum tolerated dose) of nab-paclitaxel co-administered with fixed doses of capecitabine and oxaliplatin in patients with metastatic or irresectable carcinoma of the stomach or oesophagus. Phase 2: Progression free survival;Timepoint(s) of evaluation of this end point: Phase 1: Continuously during treatment Phase 2: Every nine (9) weeks

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Secondary

Measure	Time frame
Secondary end point(s): Phase 1: 1. Adverse events, serious adverse events according to NCI CTC version 4.0 2. Response rate according to RECIST 1.1 3. Progression free survival and overall survival 4. Self-reported neurotoxicity according to the EORTC QLQ CIPN2019 Phase 2: 1. Adverse events, serious adverse events according to NCI CTC version 4.0 2. Response rate according to RECIST 1.1 3. Progression free survival and overall survival 4. Self-reported neurotoxicity according to the EORTC QLQ CIPN20;Timepoint(s) of evaluation of this end point: Phase 1: Continuously during treatment Phase 2: everynine (9) weeks	—

Measure

Time frame

Secondary end point(s): Phase 1: 1. Adverse events, serious adverse events according to NCI CTC version 4.0 2. Response rate according to RECIST 1.1 3. Progression free survival and overall survival 4. Self-reported neurotoxicity according to the EORTC QLQ CIPN2019 Phase 2: 1. Adverse events, serious adverse events according to NCI CTC version 4.0 2. Response rate according to RECIST 1.1 3. Progression free survival and overall survival 4. Self-reported neurotoxicity according to the EORTC QLQ CIPN20;Timepoint(s) of evaluation of this end point: Phase 1: Continuously during treatment Phase 2: everynine (9) weeks

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Countries

Netherlands

Contacts

Public ContactLyda ter Hofstede

Academic Medical Center

trialmedonc@amc.uva.nl0031205668229

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026