NCT00818090TerminatedPhase 2
A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma
Korean Cancer Study Group1 site in 1 country39 target enrollmentStarted: September 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Korean Cancer Study Group
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Response rate
Study Overview
Brief Summary
To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •histologically or cytologically confirmed invasive thymoma or thymic carcinoma
- •unresectable tumor: by either local invasion, distant metastasis, or recurred (assessed by investigator)
- •no previous systemic treatment for invasive thymoma or thymic carcinoma
- •at least one measurable lesion by RECIST criteria
- •18 years old or older
- •ECOG performance status 0, 1, 2
- •adequate lab. findings neutrophil ≥ 1.5 x 10^9/L platelet ≥ 75 x 10^9/L hemoglobin ≥ 9.0 g/dL bilirubin ≤ 1.5 x upper normal limit AST, ALT ≤ 2.5 x upper normal limit Alkaline phosphatase ≤ 2.5 x upper normal limit (if liver metastasis, ≤ 5 x upper normal limit) serum creatinine ≤ 1.0 x upper normal limit if serum creatinine > 1.0 x upper normal limit, creatinine clearance ≥ 60 mL/min
- •patient who agree to written, informed consent
Exclusion Criteria
- •other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection)
- •active bacterial infection
- •history of clinical trial with investigational drug within 30 days
- •radiotherapy to thoracic or mediastinal area (other area radiotherapy is permitted)
- •pregnant, or lactating women
- •patient with organ transplantation
- •peripheral neuropathy, grade 2 or greater
- •severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months active ulcer disease refractory to medication chronic obstructive lung disease requiring admission treatment within 1 year
- •uncontrolled seizure, cerebral nervous system disorder, psychiatric problem which decrease treatment compliance
Arms & Interventions
TP
Experimental
paclitaxel and cisplatin every 3 weeks
Intervention: paclitaxel and cisplatin (Drug)
Outcomes
Primary Outcomes
Response rate
Time Frame: 6 weeks, 12 weeks, 18 weeks
Secondary Outcomes
- toxicity(start of medication to 4 weeks since the last medication)
- progression-free survival(till progression)
- duration of response(till progression)
- overall survival(till death, last follow-up)
Investigators
Se-Hoon Lee
Korean Cancer Study Group
Korean Cancer Study Group
Study Sites (1)
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