A phase II study of Sutent (SU11248) as second line treatment in pleural mesothelioma after first line treatment with a platinum and antimetabolite

Completed

• Conditions: Malignant pleural mesothelioma; Cancer; Mesothelioma of pleura

• Registration Number: ISRCTN03334163
• Lead Sponsor: Sir Charles Gairdner Hospital (Australia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-02
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Patients must fulfill all the following criteria to be eligible for this study:
1. Histologically or cytologically confirmed diagnosis of malignant mesothelioma of the pleura
2. Previous therapy with at least one cycle of a platinum analogue and an antimetabolite with documented progression on, or after completion of, first-line therapy
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
4. One or more measurable lesions (by Modified Response Evaluation Criteria in Solid Tumours [RECIST] criteria)
5. Life expectancy greater than 12 weeks
6. Women of child-bearing age must use effective contraception
7. Adequate bone marrow function defined as:
7.1. Granulocyte count greater than 1.5 x 10^9/L
7.2. Platelet count greater than 100 x 10^9/L
7.3. Haemoglobin greater than 10 g/dl
8. Adequate renal function: calculated creatinine clearance (Cockcroft-Gault formula) greater than 45 ml/min
9. Adequate hepatic function defined as a total bilirubin less than Upper Limit of Normal (ULN), Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) less than 2.5 x ULN, or 1.5 x ULN if Alkaline Phosphatase (Alk Phos) less than 2.5 x ULN. Alk Phos less than 5 x ULN unless patient has bone metastases
10. Ability to give fully informed written consent according to International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and to comply with the instructions in the protocol

Exclusion Criteria

Any one of the following criteria will render a patient ineligible for this trial:
1. Previous second-line systemic chemotherapy for malignant mesothelioma
2. ECOG performance status greater than or equal to 2
3. Mesothelioma originating outside the pleura (e.g., peritoneum)
4. Previous radiotherapy to all measurable lesions
5. Symptomatic central nervous system involvement
6. Pregnancy or lactation
7. Serious concomitant systemic disorders incompatible with the study at the discretion of the investigator, e.g., severe peripheral neuropathy
8. Second primary malignancy diagnosed within the last 5 years (except for adequately treated non-melanoma skin cancers and in-situ cervical carcinoma adequately treated by cone excision)

Study & Design

• Study Type: Interventional
• Study Design: Not specified