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 November 2014 by Memorial Sloan Kettering Cancer Center.
Sponsor:
Memorial Sloan Kettering Cancer Center.
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: November 26, 2014
Last verified: November 2014
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Thymoma Thymic Carcinoma. Clinical Masaoka Stage II-IVA |
Drug: Cetuximab, Cisplatin, Doxorubicin & Cyclophosphamide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan Kettering Cancer Center.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 28 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025089
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025089
Contacts
| Contact: James Huang, MD | 646-888-3055 | ||
| Contact: Gregory Riely, MD | 212-639-3042 |
Locations
| United States, California | |
| City of Hope Medical Center | Not yet recruiting |
| Duarte, California, United States, 91010-3000 | |
| Contact: Dan Raz, MD | |
| Principal Investigator: Dan Raz, MD | |
| United States, New Jersey | |
| Memorial Sloan Kettering at Basking Ridge | Recruiting |
| Basking Ridge, New Jersey, United States, 07920 | |
| Contact: James Huang, MD | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center @ Suffolk | Recruiting |
| Commack, New York, United States, 11725 | |
| Contact: James Huang, MD | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: James Huang, MD 646-888-3055 | |
| Principal Investigator: James Huang, MD | |
| Memorial Sloan Kettering at Mercy Medical Center | Recruiting |
| Rockville Centre, New York, United States | |
| Contact: James Huang, MD | |
| Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center | Recruiting |
| Sleepy Hollow, New York, United States, 10591 | |
| Contact: James Huang, MD | |
| Memorial Sloan Kettering West Harrison | Recruiting |
| West Harrison, New York, United States, 10604 | |
| Contact: James Huang, MD 646-888-3055 | |
| United States, Texas | |
| Md Anderson Cancer Center | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: George Simon, MD | |
| Principal Investigator: George Simon, MD | |
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center.
Bristol-Myers Squibb
M.D. Anderson Cancer Center
City of Hope National Medical Center
Investigators
| Principal Investigator: | James Huang, MD | Memorial Sloan Kettering Cancer Center. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan Kettering Cancer Center. |
| ClinicalTrials.gov Identifier: | NCT01025089 History of Changes |
| Other Study ID Numbers: | 09-038 |
| Study First Received: | December 2, 2009 |
| Last Updated: | November 26, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan Kettering Cancer Center.:
|
Cetuximab Cisplatin Cyclophosphamide 09-038 |
Additional relevant MeSH terms:
|
Thymoma Thymus Neoplasms Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Thoracic Neoplasms Cetuximab Cyclophosphamide Alkylating Agents |
Antineoplastic Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015