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

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Brief Title

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

Official Title

A Phase I/Randomized Phase II Study of Cediranib (NSC#732208) Versus Placebo in Combination With Cisplatin and Pemetrexed in Chemonaive Patients With Malignant Pleural Mesothelioma

Brief Summary

      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, by stopping them from dividing, or by stopping them from
      spreading. 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.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To establish the maximum tolerated dose (MTD) and the recommended phase II dose of
      cediranib maleate (cediranib) in combination with cisplatin and pemetrexed disodium
      (pemetrexed). (Phase I) II. To assess the safety and toxicity of the regimen. (Phase I) III.
      To assess whether cisplatin/pemetrexed plus cediranib as compared to cisplatin/pemetrexed
      plus placebo improves progression-free survival in patients with malignant pleural
      mesothelioma. (Phase II) IV. To compare overall survival in patients treated with
      cisplatin/pemetrexed plus cediranib to those treated with cisplatin/pemetrexed plus placebo.
      (Phase II) V. To assess the safety and toxicity profile of the regimen. (Phase II) VI. To
      assess response rate (confirmed and unconfirmed, complete and partial responses) and disease
      control rate (response or stable disease) in the subset of patients with measurable disease
      by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. (Phase II) VII. To assess
      response rate and disease control rate using modified RECIST criteria for pleural tumors in
      the subset of patients with measurable disease by modified RECIST criteria for pleural
      tumors. (Phase II) VIII. To assess the rate of agreement between local and central pathology
      review of mesothelioma and its histologic subtypes. (Phase II) IX. To collect specimens for
      banking for use in future research studies. (Phase II)

      OUTLINE: This is a phase I dose-escalation study of cediranib maleate followed by a phase II
      study.

      PHASE I (CLOSED): Patients receive pemetrexed disodium intravenously (IV) over 10 minutes and
      cisplatin IV over 2 hours on day 1 and cediranib maleate orally (PO) once daily (QD) on days
      1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or
      unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of
      disease progression or unacceptable toxicity.

      PHASE II: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours
      on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6
      courses in the absence of disease progression or unacceptable toxicity. Patients then receive
      cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity.

      ARM II: Patients receive pemetrexed disodium and cisplatin as in arm I and placebo PO QD on
      days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease
      progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the
      absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 6 months for 2 years and
      then at 3 years.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Maximum Tolerated Dose of Cediranib in Combination With Cisplatin and Pemetrexed (Phase I)

Secondary Outcome

 Overall Survival (Phase II)

Condition

Epithelioid Mesothelioma

Intervention

Cediranib Maleate

Study Arms / Comparison Groups

 Arm I (pemetrexed disodium, cisplatin, cediranib maleate))
Description:  Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

117

Start Date

March 15, 2010


Primary Completion Date

June 1, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Patient must have histologically or cytologically confirmed diagnosis of malignant
             pleural mesothelioma; surgical resection must not be planned

          -  Patients must have measurable or non-measurable disease by both RECIST and modified
             RECIST criteria for pleural tumors as documented by computed tomography (CT) scan;
             examinations for assessment of measurable disease must have been completed within 28
             days prior to registration; examinations for assessment of non-measurable disease must
             have been performed within 42 days prior to registration; all disease must be assessed
             and documented on the RECIST 1.1 and Modified RECIST Baseline Tumor Assessment Form

          -  Patients must not have received any prior systemic therapy (chemotherapy or other
             biologic therapy) for their unresectable malignant pleural mesothelioma; prior
             systemic chemotherapy or biologic therapy is allowed as neoadjuvant or adjuvant
             treatment, disease has now recurred, and all systemic treatment was completed > 6
             months prior registration; prior therapy must not have included cediranib

          -  Patients may have received prior surgery (e.g., pleurectomy, pleurodeisis) provided at
             least 28 days have elapsed since surgery (thoracic or other major surgeries) and
             patients have recovered from all associated toxicities at the time of registration;
             there must be no anticipated need for major surgical procedures during protocol
             treatment

          -  Patients may have received prior radiation therapy provided at least 28 days have
             elapsed since the last treatment and patients have recovered from all associated
             toxicities at the time of registration

          -  Institutions must seek additional patient consent for the banking and future use of
             specimens

          -  Patient must have Zubrod performance status 0-2

          -  Absolute neutrophil count >= 1,500 mcl

          -  Platelets >= 100,000/ml

          -  Hemoglobin >= 9.0 g/dl (may be reached by transfusion)

          -  Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)

          -  Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate
             transaminase (SGPT) =< 2.5 x ULN (if liver metastases are present, SGOT or SGPT must
             be =< 5.0 x IULN)

          -  Serum creatinine =< 1.5 x IULN

          -  Calculated creatinine clearance >= 60 mL/min

          -  Urine protein must be screened by urine analysis within 28 days prior to registration;
             patient must not have greater than +1 proteinuria on two consecutive dipsticks taken
             no less than 7 days apart; however, if the first urinalysis shows no protein, then a
             repeat urinalysis is not required

          -  Patient must have an electrocardiogram (ECG) performed within 42 days prior to
             registration; patient must not have mean corrected QT (QTc) > 500 msec (with Bazett's
             correction) in screening electrocardiogram, or other significant ECG abnormality, New
             York Heart Association (NYHA) classification III or IV; patient must not require
             concurrent use of drugs or biologics with proarrhythmic potential

          -  Patient must not be receiving any medication that may markedly affect renal function
             (e.g., vancomycin, amphotericin, pentamidine)

          -  Patient must not have had clinically significant hemoptysis, defined as greater than 1
             tablespoon of bright red blood, within one year prior to registration; although
             hemoptysis has not been associated with cediranib, it may be a class effect for
             anti-angiogenic agents and therefore a risk factor for this experimental agent

          -  Patient must be able to swallow oral medications

          -  Patients must not have known human immunodeficiency virus (HIV) infection

          -  Patients must not be pregnant or nursing; women/men of reproductive potential must
             have agreed to use an effective contraceptive method; a woman is considered to be of
             "reproductive potential" if she has had menses at any time in the preceding 12
             consecutive months; in addition to routine contraceptive methods, "effective
             contraception" also includes heterosexual celibacy and surgery intended to prevent
             pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
             bilateral oophorectomy or bilateral tubal ligation; however, if at any point a
             previously celibate patient chooses to become heterosexually active during the time
             period for use of contraceptive measures outlined in the protocol, he/she is
             responsible for beginning contraceptive measures

          -  Patient must have no plans to receive concurrent chemotherapy, hormonal therapy,
             radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while
             on this protocol treatment

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             stage I or II cancer from which the patient is currently in complete remission, or any
             other cancer from which the patient has been disease free for five years
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anne S Tsao, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01064648

Organization ID

NCI-2011-02015

Secondary IDs

NCI-2011-02015

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Anne S Tsao, Principal Investigator, Southwest Oncology Group


Verification Date

August 2020