Phase 2 study of paclitaxel plus anti-EGFR as a second-line therapy for gastric and gastroesophageal junction adenocarcinomas
- Conditions
- Neoplasms
- Registration Number
- KCT0004314
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 44
Part 1. EGFR
1. Pathologically or cytologically proven gastric adenocarcinoma
2. 18 years of age or older on the date of signing the consent form
3. Patients with ECOG performance status 0-2
4. Patients with expected survival > 12 weeks
5. A person whose appropriate organ function is identified as defined in the section below:
- Hemoglobin = 9.0 g/dL
- Absolute neutrophil count (ANC) = 1.5 x 109/L (= 1,500 per mm3)
- Platelet count = 100 x 109/L (= 100,000 per mm3)
- Serum bilirubin = 1.5 x institutional upper limit of normal (ULN). (excluding Gilbert ’s syndrome)
- AST (SGOT)/ALT (SGPT) = 2.5 x institutional UNL: if there is liver metastasis = 5x ULN
- 24-h urine creatinine clearance or eGFR > 40 mL/min
6. For women, a pregnancy test is negative or non-fertile women as defined below:
- History of menopause (discontinuation of menstruation for more than 1 year without other medical reasons)
- Patients who underwent hysterectomy, bilateral ligation or bilateral ovarian resection
7. Patients willing to comply with scheduled treatment and follow-up schedules
8. EGFR focal amplification or EGFR immunostaining positive (3+) as a result of targeted sequencing. For targeted sequencing, amplification is defined as the case of copy number (CN) = 4 in cancer sequencing results, as described in detail in 6. Screening Section of Page 24 of the Plan (not applicable to the safety run-in group).
For patients whose simultaneous gene amplification of ERBB2 and EGFR are found, targeted therapy with ERBB2 should be prioritized in this trial.
9. Presence of measurable lesions on RECIST (not applicable to the safety run-in group)
10. Progression of disease after the administration of one type of anticancer drug in the treatment of metastatic gastric cancer, or progression of the disease during or within 6 months of the termination (as of the last chemotherapy date) of anticancer drug administration used as adjuvant chemotherapy;
(However, in the case of the safety run-in group, it is a rule to target disease progression after the administration of two or more anticancer drugs in the treatment of metastatic gastric cancer. If there is EGFR gene amplification or overexpression as described in # 8 above, disease progression after the administration of one anticancer agent can be listed.)
Part 1. EGFR
1. Patients with a history of allergies to taxane drugs
2. As of the first day of administration of the study drug, subjects who did not take 2 weeks after systemic chemotherapies (including immunotherapy and small molecule target therapy), who did not take 4 weeks after the administration of a monoclonal antibody or who did not take 6 weeks after the administration of nitrosourea/mitomycin C
3. History of primary cancers other than gastric cancer
except for the following cases:
- Patients who have been disease-free for more than 3 years since curative treatment of cancer and have a low risk of recurrence
- Patients currently free of non-melanoma skin cancer (lentigo maligna)
- Patient currently free of disease in situ carcinoma
4. In some circumstances, treatment or history, in which the investigator's judgment of the subject indicates that evaluation of the clinical trial results will be difficult
5. History of treatment with EGFR monoclonal antibodies or taxanes as a first-line therapy for metastatic gastric cancer
6. Uncontrolled active infections, symptomatic heart failure, uncontrolled hypertension/unstable angina/arrhythmia, active bleeding tendency, active hepatitis, mental illness or social conditions that interfere with written consent
7. Patients with a history of leptomeningeal metastasis.
8. Patients with uncontrolled symptoms of brain metastases or spinal neuralgia (patients whose symptoms have stabilized with steroids and anticonvulsants removed at least 14 days prior to the administration of the study drug are allowed)
9. Patients with uncontrolled seizures
10. Pregnant or lactating women, women of childbearing potential, or men who are not willing to use appropriate contraception within 180 days of study termination
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reaction rate as a secondary treatment
- Secondary Outcome Measures
Name Time Method Serious Adverse Event in accordance with NCI CTCAE v4.03