Description:
For the gastric cancer, paclitaxel is recommended as salvage standard treatment. Afatinib is
a novel, potent, small ErbB family blocker that covalently binds and irreversibly blocks
signaling through activated EGFR, HER2 and ErbB4 receptors, as well as the
transphosphorylation of ErbB3. The investigators suggest a randomized phase II trial of
afatinib plus weekly taxol(paclitaxel) for previously treated EGFR positive gastric cancer
patients. The aim of current trial is to evaluate the antitumor efficacy of afatinib for
target enriched patients in gastric cancer.
Title
- Brief Title: Afatinib, Paclitaxel, 2nd Line, Advanced Gastric Cancer
- Official Title: An Open-label, Multicenter Phase II Study of Afatinib Plus Weekly Taxol as Second Line Treatment for Advanced/Recurrent Gastric and Gastroesophageal Junction Cancer
Clinical Trial IDs
- ORG STUDY ID:
4-2015-0244
- NCT ID:
NCT02501603
Conditions
- Gastric Cancer
- Gastroesophageal Junction Cancer
Interventions
Drug | Synonyms | Arms |
---|
afatinib | | afatinib plus paclitaxel |
paclitaxel | | afatinib plus paclitaxel |
Purpose
For the gastric cancer, paclitaxel is recommended as salvage standard treatment. Afatinib is
a novel, potent, small ErbB family blocker that covalently binds and irreversibly blocks
signaling through activated EGFR, HER2 and ErbB4 receptors, as well as the
transphosphorylation of ErbB3. The investigators suggest a randomized phase II trial of
afatinib plus weekly taxol(paclitaxel) for previously treated EGFR positive gastric cancer
patients. The aim of current trial is to evaluate the antitumor efficacy of afatinib for
target enriched patients in gastric cancer.
Trial Arms
Name | Type | Description | Interventions |
---|
afatinib plus paclitaxel | Experimental | afatinib plus paclitaxel | |
Eligibility Criteria
Inclusion Criteria:
1. Histologically or cytologically confirmed locally advanced or metastatic gastric
cancer and gastroesophageal junction cancer
2. EGFR 2+ or 3+ expression (immunohistochemistry)
3. ECOG performance status of 0 to 1
4. Male or female; ≥ 19 years of age
5. Documented disease progression after one prior therapy, in locally advanced or
metastatic setting
6. patients received last adjuvant chemotherapy less than six months can be enrolled into
this study
7. Her2 positive patients must be progressed after prior trastuzumab based chemotherapy
8. Subjects with measurable lesion (using RECIST 1.1 criteria)
9. Subjects who meet the following criteria:
- Absolute neutrophil count (ANC) ≥ 1000 /µL (*ANC = Neutrophil segs + Neutrophil
bands)
- Platelet count ≥ 80,000/ µL
- Serum creatinine < 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥50
mL/min using Cockcroft, Gault method
- AST (SGOT) and ALT (SGPT) : 3 x upper limit of normal (ULN) (If there is Liver
Metastasis : 5 x upper limit of normal (ULN))
- Total bilirubin : 1.5 x upper limit of normal (ULN)
10. Provision of written informed consent prior to any study procedure
Exclusion Criteria:
1. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer
therapy.
2. Any previous chemotherapy or immunotherapy within 2 weeks
3. Any major operation or irradiation within 4 weeks of baseline disease assessment
4. Two or more previous systemic cytotoxic chemotherapy (adjuvant chemotherapy is not
counted)
5. Any clinically significant gastrointestinal abnormalities which may impair intake or
absorption of the study drug
6. Previously taxol(paclitaxel)-exposed patients
7. Subjects with symptomatic central nervous system (CNS) metastases who are
neurologically unstable or have required increasing doses of steroids within the 2
weeks prior to study entry to manage CNS symptoms
8. Other co-existing malignancies or malignancies diagnosed within the last 3 years with
the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.
9. Subjects with an uncontrolled major cardiovascular disease (including AMI within 12
months, unstable angina within 6 months, over NYHA class III congestive heart failure,
congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension)
10. Pregnant or lactating female
11. Patients with contraindicated medication
12. History of interstitial lung disease (ILD) or presence of ILD on chest X-ray
13. Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the patient to participate in the study
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 19 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | compare progression free survival as measured by RECIST 1.1 |
Time Frame: | Every 6 weeks until progression, an expected average of 10 months |
Safety Issue: | |
Description: | To identify antitumor activity of afatinib plus weekly taxol(paclitaxel) and explore predictive biomarker |
Secondary Outcome Measures
Measure: | antitumor efficacy as measured by RECIST 1.1 |
Time Frame: | every 6 weeks until progression, an expected average of 10 months |
Safety Issue: | |
Description: | |
Measure: | safety as measured by CTCAE |
Time Frame: | every 3 weeks until progression, an expected average of 10 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Yonsei University |
Last Updated
April 22, 2021