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Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00010257
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : October 18, 2012
Last Update Posted : October 9, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Thymoma Thymic Carcinoma Drug: carboplatin Drug: paclitaxel Phase 2

Detailed Description:


  • 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 by intravenous (IV) infusion 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 were 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 were to be accrued for this study within 3.8-4.6 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma
Study Start Date : February 2001
Actual Primary Completion Date : November 2008
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thymus Cancer

Arm Intervention/treatment
Experimental: Paclitaxel plus Carboplatin
Paclitaxel 225 mg/m2 IV over 3 hours and Carboplatin AUC 6.0 IV over 30 minutes on day 1 of a 21-day cycle
Drug: carboplatin
Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles
Other Names:
  • Paraplatin
  • JM-8
  • NSC # 241240

Drug: paclitaxel
225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles
Other Names:
  • Taxol
  • NSC #125973

Primary Outcome Measures :
  1. Best Overall Response by RECIST Criteria (Version 1.0) [ Time Frame: Assessed every 2 cycles (6 weeks) ]
    Number of eligible, treated participants in each response category by RECIST criteria

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter ]
    Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • Age 18 and over
  • ECOG Performance Status 0-1
  • Granulocyte count at least 1,500 cells/mm^3
  • Platelet count at least 100,000 cells/mm^3
  • Bilirubin no greater than 1.5 mg/dL
  • Creatinine no greater than 2.0 mg/dL
  • Concurrent corticosteroids for myasthenia gravis or other chronic conditions allowed

Exclusion Criteria:

  • Acute concurrent complications such as infection or post-surgical complications
  • Other prior malignancy within the past 5 years unless curatively treated with no evidence of recurrence
  • Pregnant or nursing. A negative pregnancy test was required, and fertile patients must use effective contraception
  • Prior chemotherapy for metastatic disease. Prior preoperative or adjuvant chemotherapy allowed if disease-free survival prior to recurrence was more than 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00010257

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Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: Patrick J. Loehrer, MD Indiana University Melvin and Bren Simon Cancer Center
Publications of Results:
Other Publications:
Loehrer PJ, Wang W, Aisner S, et al.: Long-term follow-up of patients with locally advanced or metastatic thymic malignancies: the Eastern Cooperative Oncology Group (ECOG) experience. [Abstract] J Clin Oncol 22 (Suppl 14): A-7050, 629s, 2004.

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Responsible Party: Eastern Cooperative Oncology Group Identifier: NCT00010257    
Other Study ID Numbers: CDR0000068461
U10CA021115 ( U.S. NIH Grant/Contract )
E1C99 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: October 18, 2012
Last Update Posted: October 9, 2015
Last Verified: June 2013
Keywords provided by Eastern Cooperative Oncology Group:
thymic carcinoma
Additional relevant MeSH terms:
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Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action