Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Bristol-Myers Squibb
M.D. Anderson Cancer Center
City of Hope National Medical Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01025089
First received: December 2, 2009
Last updated: August 21, 2014
Last verified: August 2014

December 2, 2009
August 21, 2014
December 2009
December 2015   (final data collection date for primary outcome measure)
To determine the frequency of complete pathologic response to neo-adjuvant therapy with cisplatin, doxorubicin, cyclophosphamide (CAP) and cetuximab in patients with clinical Masaoka stage II-IVa thymoma and thymic carcinomas. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To determine the frequency of near-complete pathologic responseto neo-adjuvant therapy with cisplatin, doxorubicin, cyclophosphamide (CAP) and cetuximab in patients with clinical Masaoka stage III-IVa thymoma. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01025089 on ClinicalTrials.gov Archive Site
  • To determine the toxicity (CTCAE v.3) of neo-adjuvant therapy with CAP and cetuximab [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To measure the radiographic response rate to cetuximab alone after 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • To determine the radiographic response rate to CAP and cetuximab [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine the complete resection rate (R0) after neo-adjuvant therapy with CAP and cetuximab [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To correlate percentage of pathologic response to unidimensional and volumetric radiographic response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma
A Phase II Trial of Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma

The main purpose of this study is to find out the good and the bad effects that the combination of cetuximab with the traditional chemotherapy regimen of cisplatin, doxorubicin, and cyclophosphamide has when given to patients with later stage thymoma or thymic carcinoma before surgery. The physicians will also look at changes in genes in the tumor that may relate to the effectiveness of cetuximab

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Thymoma
  • Thymic Carcinoma.
  • Clinical Masaoka Stage II-IVA
Drug: Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide
Patients will receive single agent cetuximab infusion starting with a 400mg/m2 IV loading dose on day 1 of week 1, followed by weekly infusions (250mg/m2) on day 1 of weeks 2 3, and 4. Patients will receive single agent cetuximab infusion starting with a 400mg/m2 IV loading dose on day 1 of week 1, followed by weekly infusions (250mg/m2) on day 1 of weeks 2 3, and 4. Patients who have completed the neo-adjuvant treatment regimen, who have no evidence of distant progression, and who are medically operable will proceed to surgical resection within 6 weeks of the last infusion.
Experimental: Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide
This is a multicenter, open-label phase II trial of neoadjuvant chemotherapy and concurrent cetuximab in patients with clinical Masaoka stage II-IVA thymoma or thymic carcinoma.. Patients will initially receive weekly cetuximab for 4 weeks to assess tumor response to cetuximab alone. Patients will then undergo weekly cetuximab along with concurrent CAP for 4 cycles. At the completion of this regimen, patients will undergo surgical resection and the specimen will be evaluated for CPR.
Intervention: Drug: Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age>18
  • Karnofsky Performance Status (KPS) ≥ 70
  • Newly diagnosed or recurrent thymoma - WHO A, AB, B1, B2, or B340, or thymic carcinoma pathologically confirmed at MSKCC, MDACC or City of Hope
  • No prior chemotherapy, radiotherapy, or surgical therapy (other than for diagnostic biopsy) for thymoma
  • No prior treatment with cetuximab
  • Clinical Masaoka Stage II (>5cm), III, or IVA(See Appendix B), including suspected invasion of mediastinum, pericardium, lung, great vessels or chest wall, and/or pleural metastases Normal marrow function: leukocytes ≥ 4,000/μl, absolute neutrophil count ≥ 1,500/μl, platelets ≥ 160,000/μl
  • Adequate renal function, with creatinine ≤ 1.3 mg/dl or calculated creatinine clearance ≥60ml/min by Cockcroft and Gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)
  • Adequate hepatic function: Total bilirubin ≤1.5 mg/dl, AST ≤1.5X UNL, alkaline phosphatase ≤1.5 UN
  • Signed informed consent
  • Effective contraception
  • Medically operable

Exclusion Criteria:

  • Evidence of distant metastatic disease (Masaoka stage IVB)
  • Thymic carcinoid
  • Patients must not be receiving any other investigational agents
  • Concurrent or prior malignancy in the last 5 years other than non-melanoma skin cancer and in-situ carcinoma of the cervix
  • Known HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs. Patients on medications known to alter CYP3A4
  • Pregnant or breastfeeding women
Both
18 Years and older
No
Contact: James Huang, MD 646-888-3055
Contact: Gregory Riely, MD 212-639-3042
United States
 
NCT01025089
09-038
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Bristol-Myers Squibb
  • M.D. Anderson Cancer Center
  • City of Hope National Medical Center
Principal Investigator: James Huang, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2014

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