Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy

  • Interventional
  • Not Recruiting
  • NCT01085630
Eligibility Details Visit Clinicaltrials.gov

Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy.

OBJECTIVES:

     Primary

        - To determine if maintenance therapy with pemetrexed disodium versus observation improves progression-free survival of patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy comprising pemetrexed disodium with cisplatin or carboplatin.

     Secondary

        - To determine the overall survival of patients treated with this regimen versus observation.

        - To evaluate the frequency of responses in patients treated with this regimen.

        - To assess the toxicity of this regimen in these patients.

     OUTLINE: This is a multicenter study. Patients are stratified according to first-line chemotherapy regimen (cisplatin/pemetrexed disodium vs carboplatin/pemetrexed disodium), histologic subtype (epithelioid vs other) and number of courses received (< 6 vs 6).

        - Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

        - Arm II: Patients undergo observation until disease progression. After completion of study therapy, patients are followed up every 6 months for 3 years.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Histologically confirmed malignant pleural mesothelioma meeting 1 of the following cell types:

             - Epithelial

             - Sarcomatoid

             - Mixed type

             - Histologically documented malignant pleural mesothelioma, epithelial, sarcomatoid or mixed type, not amenable to surgical resection

             - Prior treatment

         - Currently receiving first-line treatment with pemetrexed + platinum; patients are to be registered to Cancer and Leukemia Group B (CALGB) 30901 no later than the last day of cycle 4 of first line therapy

         - Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) are acceptable; prior intrapleural cytotoxic chemotherapy will not be considered systemic chemotherapy

         - Prior surgical treatment is allowed

         - Prior radiation therapy is allowed

             - Non-pregnant and non-nursing; women of child bearing potential and men must agree to use an appropriate method of birth control throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier methods (diaphragm plus condom)

             - RANDOMIZATION ELIGIBILITY CRITERIA

             - Patients with complete response, partial response, or stable disease following 4, 5 or 6 cycles of first-line chemotherapy with pemetrexed AND either cisplatin or carboplatin; a maximum of 6 cycles of chemotherapy may have been given

             - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

             - Granulocytes >= 1,500/ul

             - Platelet count >= 100,000/ul

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

             - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2 x ULN

             - Calculated creatinine clearance >= 45 ml/min

         - Disease not amenable to surgery

         - Must be enrolled on imaging protocol CALGB-580903

         - Complete response, partial response, or stable disease after completion of 4 courses of first-line chemotherapy comprising pemetrexed disodium AND cisplatin or carboplatin

             - Study therapy will begin within 9 weeks following day 1 of cycle 4 of first-line treatment

         - No clinically significant pleural or peritoneal effusions that cannot be adequately managed by drainage before or during pemetrexed disodium

        PATIENT CHARACTERISTICS:

         - ECOG performance status of 0-1

         - Life expectancy ≥ 12 weeks

         - Granulocytes ≥ 1,500/μL

         - Platelet count ≥ 100,000/μL

         - Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

         - AST ≤ 2 times ULN

         - Creatinine clearance ≥ 45 mL/min

         - Not pregnant or nursing

         - Negative pregnancy test

         - Fertile patients must use effective contraception

         - No psychiatric illness that would prevent the patient from giving informed consent

         - No second malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix unless curatively treated with no evidence of active disease for ≥ 5 years

         - No medical conditions that, in the opinion of the treating physician, would make study treatment unreasonably hazardous for the patient including, but not limited to, the following:

             - Ongoing or active infection such as HIV positivity

             - Inability to take oral medications

             - Psychiatric illness/social situations that would limit compliance with study requirements

        PRIOR CONCURRENT THERAPY:

         - See Disease Characteristics

         - Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) allowed

             - Prior intrapleural cytotoxic chemotherapy not considered systemic chemotherapy

         - Prior surgery allowed

         - Prior radiotherapy allowed

             - No concurrent palliative radiotherapy

         - No concurrent hormones or other chemotherapeutic agents except for the following:

             - Steroids for adrenal failure

             - Hormones for nondisease-related conditions (e.g., insulin for diabetes)

             - Intermittent use of dexamethasone as an antiemetic or premedication for pemetrexed disodium
  • Cancer
  • Malignant Mesothelioma

At a Glance

National Government IDNCT01085630

IRB#10-290-A

Lead SponsorAlliance for Clinical Trials in Oncology

Lead PhysicianHedy Kindler

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting