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Phase II trial of paclitaxel (T) vs Irinotecan(I) in patients with extensive disease (ED) small cell lung cancer (SCLC) as 2nd line chemotherapy

Phase II trial of paclitaxel (T) vs Irinotecan(I) in patients with previously Etoposide/platinum (EP) treated, extensive disease (ED) small cell lung cancer (SCLC) as 2nd line chemotherapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0003330
Enrollment
136
Registered
2018-11-09
Start date
2018-12-01
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Drug : This clinical trial was to compare the efficacy and safety of taxol chemotherapy and irinotecan chemotherapy in patients with previously treated advanced stage small cell lung cancer. Patients

Sponsors

Chung-Ang Univerisity Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically diagnosed dilated stage small cell lung cancer patient 2) Patients who were treated with etoposide / platinum combination therapy as a first-line treatment and who had more than partial response (PR) and sustained more than 90 days. However, it is a rule to keep it for more than 90 days, but it is also possible to register patients who are kept for more than 60 days. 3) In the presence of brain metastases with neurological symptoms, previous radiation therapy or surgical treatment for brain metastases was neurologically stable (no progressive neurological symptoms, and steroid therapy was discontinued). Radiation therapy The researcher has determined that the toxicity of 4) When radiation therapy is applied to areas other than the brain, it can be selected when the scope of irradiation does not include target lesions 5) Appropriate bone marrow, liver, new function Serum creatinine ? Normal upper limit of each organ (UNL) Serum transaminase = UNL x 2.0 (if there is liver damage ? UNL x 5 Serum bilirubin ? UNL x 1.5 neutrophil count ? 1,500 / uL, platelets ? 100,000 / uL 6) If there is more than one measurable lesion based on RECIST criteria 7) 20 years old or older 8) Eastern Cooperative Oncology Group (ECOG) Activity 0-2 9) Have obtained written consent based on the guidelines of each institutional clinical trial committee

Exclusion criteria

Exclusion criteria: 1) Patients with brain metastases whose symptoms are not adequately controlled 2) Patients with significant infectious disease to which parenteral antibiotics should be administered 3) diarrhea patients whose symptoms are not adequately controlled 4) Chronic inflammatory bowel disease whose symptoms are not adequately controlled 5) Patients with bowel obstruction, bowel obstruction 6) Patients with interstitial pneumonia or pulmonary fibrosis 7) Patients with dialysis 8) Pregnant or potentially pregnant women and lactating women 9) Patients receiving Atazanavir Sulfate 10) Patients who have a history of hypersensitivity reactions to xylitol or its components. Patients with a history of severe hypersensitivity to other drugs containing Cremophor® EL (polyoxyethylated castor oil) 11) Large amount of ascites, pleural effusion 12) Patients receiving St. John's Wort

Design outcomes

Primary

MeasureTime frame
Response rates between two group

Secondary

MeasureTime frame
Overall survival between two group;Progression free survival between two group;Toxicity between two group

Countries

Korea, Republic of

Contacts

Public ContactSong Ee Park

Chung-Ang Univerisity Hospital

putoto@naver.com+82-2-6299-3043

Outcome results

None listed

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