Clinical trial · Interventional
Phase I/II Study of Paclitaxel Plus CPT-11 in Pts. With 2nd Line Chemotherapy of Inoperable or Recurrent GC.
Phase I/II Study of Biweekly Administration Regimen of Paclitaxel Combined With CPT-11 in Patients With Second Line Chemotherapy of Inoperable or Recurrent Gastric Cancer(GC).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to strong side effect
Summary
Brief summary (as posted)
A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using CPT-11 and Paclitaxel in pre-treated patients with metastatic gastric cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Campt, Topotesin | Drug | — | UNRESOLVED |
| Taxol | Drug | Taxol | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Paclitaxel+Irinotecan
- interventionNames
- Drug: Taxol
- Drug: Campt, Topotesin
Primary outcomes (1)
- measure
- Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting.
- timeFrame
- 1-year
Secondary outcomes (2)
- measure
- Determine the clinical response rate of patients in Phase I setting.
- timeFrame
- 1-year
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic or recurrent gastric cancer with prior treatment for advanced disease. * Patients who have received 1cycle cancer therapy (radiotherapy, chemotherapy or chemoradiotherapy) given \> 4 weeks prior to the beginning of study therapy * At least one measurable lesion according to the RECIST criteria. Minimum indicator lesion size: \> 10 mm measured by spiral CT or \>20mm measured by conventional techniques(Except for Phase I setting). * Patients aged between 20 and 75 years, inclusive, at the time of acquisition of informed consent * Patients with performance status(ECOG) 0 to 2 * Abnormal hematologic values (WBC ≥ 3.5 x 109/L, Hemoglobin ≥ 9.0g/dl, platelet count ≥ 100 x 109/L) * Serum cleatinine ≤ 1.5mg/dl * Serum bilirubin ≤ 1.5mg/dl. ALT, AST ≤ 2.0 x upper normal limit (or ≤ 3 x upper normal limit in the case of liver metastases) * Normal ECG * Life expectancy ≥ 3 months * Patients who have given written informed consent to participate in this study Exclusion Criteria: * Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer) (Except for Phase I setting) * Serious, uncontrolled, concurrent infection(s) or illness(es) * Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia) * Patients with Liver cirrhosis * Patients with fresh hemorrhage from the gastrointestinal tract * Patients with poorly controlled diabetes or are treated by continuous use of insulin * Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study * Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment * Patients with diarrhea (watery stool) * Patients with infection, intestinal palsy or intestinal occlusion * Patients with brain metastasis * Patients with Gilbert syndrome * Patients who have experienced serious drug allergy in the past * Patients who are pregnant and lactating or hope to become pregnant during the study period * Patients with prior Taxan (Paclitaxel, Docetaxel) or CPT-11 treatment * Patients with neuropathy ≥ grade 2 * Others, patients judged by the investigator or subinvestigator to be inappropriate as subject
References
Publications (0)
Data not yet available