Combination Chemotherapy With or Without Surgery and Chemoradiotherapy in Treating Patients With Malignant Pleural Mesothelioma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00354393
First received: July 19, 2006
Last updated: February 6, 2009
Last verified: October 2007
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Purpose
RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinorelbine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin may also make tumor cells more sensitive to radiation therapy. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without surgery and chemoradiotherapy works in treating patients with malignant pleural mesothelioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: cisplatin Drug: methotrexate Drug: vinorelbine ditartrate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma |
Resource links provided by NLM:
Drug Information available for:
Methotrexate
Methotrexate sodium
Cisplatin
Vinorelbine
Vinorelbine tartrate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Response to chemotherapy [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tolerability and toxicity [ Designated as safety issue: Yes ]
- Relapse free and overall survival [ Designated as safety issue: No ]
- Operability and surgical success [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | August 2002 |
OBJECTIVES:
Primary
- Assess the response to induction combination chemotherapy comprising methotrexate, vinorelbine ditartrate, and cisplatin in patients with previously untreated malignant pleural mesothelioma.
Secondary
- Assess the tolerability and toxicity of this regimen in these patients.
- Determine relapse-free and overall survival of patients treated with induction combination chemotherapy with or without surgery and hemithoracic radiation.
- Assess the impact of induction combination chemotherapy on operability and surgical success.
- Evaluate the impact of these treatment regimens on quality of life.
OUTLINE:
- Induction chemotherapy: Patients receive MVP chemotherapy comprising cisplatin IV over 30-60 minutes on day 1 and vinorelbine ditartrate IV over 5-10 minutes and methotrexate IV over 5-30 minutes on days 8, 15, and 22. Treatment repeats every 28 days for 2 courses. Patients with unresectable disease may receive up to 2 additional courses of induction chemotherapy. Patients requiring palliative radiotherapy or who have progressive disease are removed from the study. Patients with resectable disease or sarcomatoid histology and T1-3, N1-2 disease with a complete or partial response to induction chemotherapy proceed to surgery.
- Surgery: Patients with extensive disease undergo palliative debulking pleurectomy and decortication and then are taken off study. All other patients undergo a thoracotomy with an extrapleural pneumonectomy and then proceed to chemoradiotherapy.
- Chemoradiotherapy: Beginning 6-10 weeks after surgery, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients also receive cisplatin IV over 30-60 minutes on days 1 and 22. Patients with responding disease proceed to adjuvant chemotherapy.
- Adjuvant chemotherapy: Patients receive 2 additional courses of MVP chemotherapy as above.
Quality of life is assessed at baseline, after each course of induction chemotherapy, before surgery, and then every 3 months thereafter.
After completion of study therapy, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignant pleural mesothelioma
Amenable to aggressive surgical resection, if deemed resectable
Patients with potentially resectable disease must have undergone mediastinoscopy to establish surgical stage
Resectable disease is defined as any of the following:
- Epithelioid, mixed histology, or histology not otherwise specified with clinical stage I-III (T1-3, N0-2, M0) disease
- Sarcomatoid histology with clinical stage I-III (T1-3, N0) disease
Intraperitoneal extension, contralateral thoracic extension, or distant metastases are eligible, but considered unresectable
- Disease considered unresectable by any medical reason or if surgery was declined
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 3,000/mm³
- Platelet count > 100,000/mm³
- Creatinine ≤ 1.7 mg/dL
- Alkaline phosphatase < 2 times normal
- AST < 2 times normal
- Albumin > 3 g/dL
- Bilirubin < 2.0 mg/dL
- Patients must be available for and compliant with adequate long-term follow-up
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Patients with resectable disease must have adequate pulmonary function to undergo surgery and radiotherapy
- No other active malignancies
PRIOR CONCURRENT THERAPY:
- No prior surgical resection, radiation therapy, chemotherapy, or immunotherapy for this cancer
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354393
Locations
| United States, Ohio | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Study Chair: | David J. Adelstein, MD | Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00354393 History of Changes |
| Other Study ID Numbers: | CDR0000486304, CASE-CCF-IRB-5179, CASE-CCF-0755 |
| Study First Received: | July 19, 2006 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
localized malignant mesothelioma sarcomatous mesothelioma advanced malignant mesothelioma epithelial mesothelioma |
Additional relevant MeSH terms:
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Vinorelbine Cisplatin Methotrexate Vinblastine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Phytogenic Tubulin Modulators |
ClinicalTrials.gov processed this record on May 16, 2013