Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma

NCT00227630 | Completed Phase 2

• 2 other identifiers: EORTC-080312004-004273-28
• Study Type: interventional
• Target: 59
• Locations: 4 countries
• Sites: 8

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin followed by surgery and radiation therapy works in treating patients with malignant pleural mesothelioma.

Conditions

Malignant Mesothelioma

Keywords

epithelial mesothelioma; sarcomatous mesothelioma; localized malignant mesothelioma; recurrent malignant mesothelioma

Outcome Measures

Primary Outcomes (1)

• Feasibility in terms of 90-day progression-free survival

Secondary Outcomes (3)

• Toxicity

• Progression-free survival

• Overall survival

Interventions

cisplatin DRUG

pemetrexed disodium DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed malignant pleural mesothelioma * All subtypes allowed * T1-3, N0-1, M0 disease * No N2 or N3 involvement confirmed by mediastinoscopy within 21 days before study entry * No clinical invasion of mediastinal structures (e.g., heart, aorta, spine, esophagus) * No wide-spread chest wall invasion except focal chest wall lesions * No clinical or radiological evidence of shrinking hemithorax * No clinically significant third-space fluid (e.g., pleural effusions or ascites) that cannot be managed with thoracentesis or pleurodesis PATIENT CHARACTERISTICS: Age * Under 70 Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * WBC \> 3,500/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin ≥ 11 g/dL Hepatic * AST and ALT \< 1.5 times upper limit of normal (ULN) * Bilirubin \< 1.5 times ULN * Alkaline phosphatase \< 1.5 times ULN Renal * Creatinine clearance ≥ 60 mL/min * Acceptable (predicted) post-radiotherapy renal function by semiquantitative isotope renography, with a relative contribution of the contralateral kidney of ≥ 40% Pulmonary * See Disease Characteristics Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * Deemed to be fit enough to undergo study treatment * No preexisting sensory neurotoxicity \> grade 1 * No uncontrolled infection * No prior or concurrent melanoma, breast cancer, or hypernephroma * No other malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell skin cancer * No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy * No concurrent routine use of colony-stimulating factors during neoadjuvant chemotherapy * Concurrent secondary prophylactic use allowed during neoadjuvant chemotherapy * No concurrent secondary prophylactic use of colony-stimulating factors during post-operative radiotherapy Chemotherapy * No prior chemotherapy for mesothelioma Endocrine therapy * No concurrent hormonal cancer therapy Radiotherapy * No prior radiotherapy to the lower neck, thorax, or upper abdomen Surgery * See Disease Characteristics Other * No other concurrent anticancer therapy * No other concurrent experimental medications * No nonsteroidal anti-inflammatory drugs or salicylates for 2 days before, during, and 2 days after administration of neoadjuvant chemotherapy (5 days before and 2 days after for drugs with a long half-life \[e.g., naproxen, piroxicam, diflunisal, or nabumetone\])

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (8)

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

Location

Azienda Ospedaliera Di Parma

Parma, 43100, Italy

Location

Universita Degli Studi di Udine

Udine, 33100, Italy

Location

Sint Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, HU8 9HE, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Related Publications (2)

• O'Brien ME, Konopa K, Lorigan P, Bosquee L, Marshall E, Bustin F, Margerit S, Fink C, Stigt JA, Dingemans AM, Hasan B, Van Meerbeeck J, Baas P. Randomised phase II study of amrubicin as single agent or in combination with cisplatin versus cisplatin etoposide as first-line treatment in patients with extensive stage small cell lung cancer - EORTC 08062. Eur J Cancer. 2011 Oct;47(15):2322-30. doi: 10.1016/j.ejca.2011.05.020. Epub 2011 Jun 16.

  PMID: 21684151 RESULT

• Van Schil PE, Baas P, Gaafar R, Maat AP, Van de Pol M, Hasan B, Klomp HM, Abdelrahman AM, Welch J, van Meerbeeck JP; European Organisation for Research and Treatment of Cancer (EORTC) Lung Cancer Group. Trimodality therapy for malignant pleural mesothelioma: results from an EORTC phase II multicentre trial. Eur Respir J. 2010 Dec;36(6):1362-9. doi: 10.1183/09031936.00039510. Epub 2010 Jun 4.

  PMID: 20525721 RESULT

MeSH Terms

Conditions

Mesothelioma, Malignant; Solitary Fibrous Tumor, Pleural

Interventions

Cisplatin; Pemetrexed; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Solitary Fibrous Tumors; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Paul Van Schil, MD, PhD

  University Hospital, Antwerp

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: July 1, 2005
• Primary Completion: August 1, 2007
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

BE (1); IT (3); NL (2); GB (2)