Paclitaxel and Cisplatin for Thymic Neoplasm
This study has been terminated.
(marginal statistical significance)
Sponsor:
Korean Cancer Study Group
Information provided by (Responsible Party):
Se-Hoon Lee, Korean Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00818090
First received: January 5, 2009
Last updated: April 11, 2013
Last verified: September 2012
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Purpose
To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma
| Condition | Intervention | Phase |
|---|---|---|
|
Thymoma Thymic Carcinoma |
Drug: paclitaxel and cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma |
Resource links provided by NLM:
Further study details as provided by Korean Cancer Study Group:
Primary Outcome Measures:
- Response rate [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- toxicity [ Time Frame: start of medication to 4 weeks since the last medication ] [ Designated as safety issue: Yes ]
- progression-free survival [ Time Frame: till progression ] [ Designated as safety issue: No ]
- duration of response [ Time Frame: till progression ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: till death, last follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 39 |
| Study Start Date: | September 2008 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TP
paclitaxel and cisplatin every 3 weeks
|
Drug: paclitaxel and cisplatin
paclitaxel and cisplatin every 3 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818090
Locations
| Korea, Republic of | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
Korean Cancer Study Group
Investigators
| Principal Investigator: | Dae Seog Heo, MD, PhD | Seoul National University |
More Information
No publications provided
| Responsible Party: | Se-Hoon Lee, Korean Cancer Study Group |
| ClinicalTrials.gov Identifier: | NCT00818090 History of Changes |
| Other Study ID Numbers: | KCSG-LU08-03; CRCST-L-0003 |
| Study First Received: | January 5, 2009 |
| Last Updated: | April 11, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Korean Cancer Study Group:
|
thymic epithelial tumor paclitaxel cisplatin thymic carcinoma invasive thymoma |
Additional relevant MeSH terms:
|
Carcinoma Thymoma Thymus Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Complex and Mixed Thoracic Neoplasms Neoplasms by Site Lymphatic Diseases Cisplatin |
Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013