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.

Study Overview

• Status: Completed
• Conditions: Thymic Carcinoma; Thymoma
• Intervention / Treatment: Drug: carboplatin; Drug: paclitaxel

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Aurora, Illinois, United States, 60507
      • Rush-Copley Cancer Care Center
    • Joliet, Illinois, United States, 60435
      • Joliet Oncology-Hematology Associates, Limited - West
    • Rockford, Illinois, United States, 61104-2315
      • Swedish-American Regional Cancer Center
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center at Carle Foundation Hospital
    • Urbana, Illinois, United States, 61801
      • CCOP - Carle Cancer Center
  • Indiana
    • Michigan City, Indiana, United States, 46360
      • Saint Anthony Memorial Health Centers
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • Cedar Rapids Oncology Associates
    • Sioux City, Iowa, United States, 51101
      • Siouxland Hematology-Oncology Associates, LLP
    • Sioux City, Iowa, United States, 51104
      • St. Luke's Regional Medical Center
    • Sioux City, Iowa, United States, 51104
      • Mercy Medical Center - Sioux City
  • Michigan
    • Escanaba, Michigan, United States, 49431
      • Green Bay Oncology, Limited - Escanaba
    • Iron Mountain, Michigan, United States, 49801
      • Dickinson County Healthcare System
    • Kalamazoo, Michigan, United States, 49007
      • Bronson Methodist Hospital
    • Kalamazoo, Michigan, United States, 49001
      • Borgess Medical Center
    • Kalamazoo, Michigan, United States, 49007-3731
      • West Michigan Cancer Center
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Fairview Ridges Hospital
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy and Unity Cancer Center at Mercy Hospital
    • Edina, Minnesota, United States, 55435
      • Fairview Southdale Hospital
    • Fridley, Minnesota, United States, 55432
      • Mercy and Unity Cancer Center at Unity Hospital
    • Hutchinson, Minnesota, United States, 55350
      • Hutchinson Area Health Care
    • Litchfield, Minnesota, United States, 55355
      • Meeker County Memorial Hospital
    • Maplewood, Minnesota, United States, 55109
      • Minnesota Oncology Hematology, PA - Maplewood
    • Maplewood, Minnesota, United States, 55109
      • HealthEast Cancer Care at St. John's Hospital
    • Minneapolis, Minnesota, United States, 55407
      • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center - Minneapolis
    • Robbinsdale, Minnesota, United States, 55422-2900
      • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
    • Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Metro-Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Cancer Center
    • Saint Paul, Minnesota, United States, 55102
      • United Hospital
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital Cancer Care Center
    • Saint Paul, Minnesota, United States, 55102
      • HealthEast Cancer Care at St. Joseph's Hospital
    • Shakopee, Minnesota, United States, 55379
      • St. Francis Cancer Center at St. Francis Medical Center
    • Waconia, Minnesota, United States, 55387
      • Ridgeview Medical Center
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Oncology Hematology, PA - Woodbury
    • Woodbury, Minnesota, United States, 55125
      • HealthEast Cancer Care at Woodwinds Health Campus
  • New Jersey
    • Flemington, New Jersey, United States, 08822
      • Hunterdon Regional Cancer Center at Hunterdon Medical Center
    • Hackensack, New Jersey, United States, 07601
      • CCOP - Northern New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Ohio
    • Canton, Ohio, United States, 44710-1799
      • Aultman Cancer Center at Aultman Hospital
    • Cleveland, Ohio, United States, 44106-5065
      • Case Comprehensive Cancer Center
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Cancer Care Center at MetroHealth Medical Center
    • Lima, Ohio, United States, 45801
      • St. Rita's Medical Center
  • Pennsylvania
    • Darby, Pennsylvania, United States, 19023
      • Mercy Fitzgerald Hospital
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Cancer Institute at Milton S. Hershey Medical Center
    • Lewistown, Pennsylvania, United States, 17044
      • Lewistown Hospital
    • Media, Pennsylvania, United States, 19063
      • Riddle Memorial Hospital Cancer Center
    • Philadelphia, Pennsylvania, United States, 19111-2497
      • Fox Chase Cancer Center - Philadelphia
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Cancer Center
    • Scranton, Pennsylvania, United States, 18510
      • Hematology and Oncology Associates of Northeastern Pennsylvania
    • State College, Pennsylvania, United States, 16803
      • Mount Nittany Medical Center
    • Upland, Pennsylvania, United States, 19013
      • Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Regional Hospital
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
    • Sioux Falls, South Dakota, United States, 57105
      • Medical X-Ray Center, PC
    • Sioux Falls, South Dakota, United States, 57117-5039
      • Sanford Cancer Center at Sanford USD Medical Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54307-3508
      • St. Vincent Hospital Regional Cancer Center
    • Green Bay, Wisconsin, United States, 54301-3526
      • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
    • Green Bay, Wisconsin, United States, 54303
      • Green Bay Oncology, Limited at St. Mary's Hospital
    • Green Bay, Wisconsin, United States, 54303
      • St. Mary's Hospital Medical Center - Green Bay
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
    • Marinette, Wisconsin, United States, 54143
      • Bay Area Cancer Care Center at Bay Area Medical Center
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic - Marshfield Center
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin Cancer Center
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital and Medical College of Wisconsin
    • Oconto Falls, Wisconsin, United States, 54154
      • Green Bay Oncology, Limited - Oconto Falls
    • Rice Lake, Wisconsin, United States, 54868
      • Marshfield Clinic - Indianhead Center
    • Sturgeon Bay, Wisconsin, United States, 54235
      • Green Bay Oncology, Limited - Sturgeon Bay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: CBDCA; JM-8; Paraplatin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Overall Response by RECIST Criteria (Version 1.0)	Number of eligible, treated participants in each response category by RECIST criteria	Assessed every 2 cycles (6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response	Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria	assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter

Collaborators and Investigators

• Sponsor: Eastern Cooperative Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Patrick J. Loehrer, MD, Indiana University Melvin and Bren Simon Cancer Center

Publications and helpful links

General Publications

• Lemma GL, Lee JW, Aisner SC, Langer CJ, Tester WJ, Johnson DH, Loehrer PJ Sr. Phase II study of carboplatin and paclitaxel in advanced thymoma and thymic carcinoma. J Clin Oncol. 2011 May 20;29(15):2060-5. doi: 10.1200/JCO.2010.32.9607. Epub 2011 Apr 18.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2001
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: February 2, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimated): January 27, 2003

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: thymoma; thymic carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Thoracic Neoplasms; Neoplasms, Complex and Mixed; Carcinoma; Thymoma; Thymus Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: CDR0000068461; U10CA021115 (U.S. NIH Grant/Contract); E1C99 (Other Identifier: Eastern Cooperative Oncology Group (ECOG))