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Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma
This study has been completed.
Study NCT00010257   Information provided by National Cancer Institute (NCI)
First Received: February 2, 2001   Last Updated: April 14, 2009   History of Changes

February 2, 2001
April 14, 2009
February 2001
November 2008   (final data collection date for primary outcome measure)
Objective response rate [ Designated as safety issue: No ]
Objective response rate
Complete list of historical versions of study NCT00010257 on ClinicalTrials.gov Archive Site
  • Duration of response [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Duration of response
  • Toxicity
 
Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma
Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.

OBJECTIVES:

  • Determine the objective response rate in patients with advanced thymoma or thymic carcinoma treated with carboplatin and paclitaxel.
  • Determine the duration of response in these patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression. Patients achieving complete or partial remission or stable disease receive 4 additional courses of therapy for a maximum of 6 courses. Further treatment may be given at the discretion of the treating physician.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 35-68 patients will be accrued for this study within 3.8-4.6 years.

Phase II
Interventional
Treatment
Thymoma and Thymic Carcinoma
  • Drug: carboplatin
  • Drug: paclitaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
46
 
November 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery

    • Extensive disease (distant disease, pleural disease, pulmonary with or without mediastinal disease, or recurrent progressive disease in site of prior radiotherapy)
    • Advanced limited disease allowed if ineligible for primary radiotherapy or surgery
  • Measurable disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500 cells/mm^3
  • Platelet count at least 100,000 cells/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • No acute concurrent complications such as infection or post-surgical complications
  • No other prior malignancy within the past 5 years unless curatively treated with no evidence of recurrence
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for metastatic disease
  • Prior preoperative or adjuvant chemotherapy allowed if disease-free survival prior to recurrence was more than 1 year

Endocrine therapy:

  • Concurrent corticosteroids for myasthenia gravis or other chronic conditions allowed

Radiotherapy:

  • See Disease Characteristics
  • No concurrent local radiotherapy for pain control or life threatening situations

Surgery:

  • See Disease Characteristics
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010257
Robert L. Comis, ECOG Group Chair's Office
CDR0000068461, ECOG-1C99, NCI-E1C99
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Patrick J. Loehrer, MD Indiana University Melvin and Bren Simon Cancer Center
National Cancer Institute (NCI)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP