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Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma

This randomized phase I/II trial is studying the side effects and best dose of cediranib maleate when given together with pemetrexed disodium and cisplatin and to see how well it works in treating patients with malignant pleural mesothelioma.

Drugs used in chemotherapy, 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. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving pemetrexed disodium and cisplatin together with cediranib maleate may kill more tumor cells.

  • Start Date: May 2010
  • Primary Completion Date: March 2011
  • Completion Date: Unknown
  • Last Updated Date: October 14, 2010

Criteria

Disease Characteristics

  • Histologically or cytologically confirmed malignant pleural mesothelioma
    • Not planning to undergo surgical resection
  • Measurable or non-measurable disease by RECIST or modified RECIST criteria for pleural tumors as documented by CT scan

Patient Characteristics

  • Zubrod performance status 0-2
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL (transfusion allowed)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases are present)
  • Serum creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 60 mL/min
  • Proteinuria ≤ +1 on 2 consecutive dipsticks taken ≥ 7 days apart
    • Repeat urinalysis not required provided first urinalysis shows no protein
  • Not pregnant or nursing
  • Fertile patients must agree to use effective contraception
  • Must be able to swallow oral medications
  • No mean QTc > 500 msec (with Bazett correction) by ECG or other significant ECG abnormality
  • No NYHA class III-IV congestive heart failure
  • No clinically significant hemoptysis, defined as > 1 tablespoon of bright red blood, within the past year
  • No known HIV infection
  • No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer from which the patient is currently in complete remission

Prior Concurrent Therapy

  • See Disease Characteristics
  • No prior systemic therapy (chemotherapy or other biological therapy) for unresectable malignant pleural mesothelioma
    • Prior systemic chemotherapy or biologic therapy as neoadjuvant or adjuvant therapy allowed provided disease has recurred and systemic therapy was completed > 6 months before study entry
  • No prior therapy with any of the study drugs
  • At least 28 days since prior surgery (e.g., pleurectomy, pleurodeses, thoracic or other major surgeries) and recovered
  • At least 28 days since prior radiotherapy and recovered
  • No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
  • No concurrent drugs or biologics with proarrhythmic potential
  • No concurrent major surgery
  • No other concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064648

For further information or to enroll in this trial, please contact one of the following locations:

Highlands Oncology Group
Bentonville, Arkansas 72712
Contact: Joseph T. Beck, M.D., FACP
479-587-1700

Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky 40536
859-257-3379

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
800-865-1125

M.D. Anderson Cancer Center at University of Texas
Houston, Texas 77030
713-792-3245

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