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Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma
This study has been completed.
First Received: February 2, 2001   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00010257
  Purpose

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 Intervention Phase
Thymoma and Thymic Carcinoma
Drug: carboplatin
Drug: paclitaxel
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 46
Study Start Date: February 2001
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010257

  Show 67 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Patrick J. Loehrer, MD Indiana University Melvin and Bren Simon Cancer Center
  More Information

Additional Information:
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.

Responsible Party: ECOG Group Chair's Office ( Robert L. Comis )
Study ID Numbers: CDR0000068461, ECOG-1C99, NCI-E1C99
Study First Received: February 2, 2001
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00010257     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
invasive thymoma and thymic carcinoma
recurrent thymoma and thymic carcinoma

Study placed in the following topic categories:
Thoracic Neoplasms
Paclitaxel
Tubulin Modulators
Thymoma
Thymus Neoplasms
Antimitotic Agents
Carboplatin
Antineoplastic Agents, Phytogenic
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Thymoma
Thymus Neoplasms
Antineoplastic Agents, Phytogenic
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009