Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00010257
First received: February 2, 2001
Last updated: June 18, 2013
Last verified: June 2013
  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
Thymic Carcinoma
Drug: carboplatin
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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 Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Best Overall Response by RECIST Criteria (Version 1.0) [ Time Frame: Assessed every 2 cycles (6 weeks) ] [ Designated as safety issue: No ]
    Number of eligible, treated participants in each response category by RECIST criteria


Secondary Outcome Measures:
  • Duration of Response [ Time Frame: assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter ] [ Designated as safety issue: No ]
    Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria


Enrollment: 46
Study Start Date: February 2001
Study Completion Date: August 2012
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • CBDCA
  • 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

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 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.

  Eligibility

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

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
  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: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00010257     History of Changes
Other Study ID Numbers: CDR0000068461, U10CA021115, E1C99
Study First Received: February 2, 2001
Results First Received: September 17, 2012
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
thymoma
thymic carcinoma

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

ClinicalTrials.gov processed this record on April 15, 2014