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

Brief Summary

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.

Tracking Information
First Received DateMarch 11, 2010
Last Changed DateMarch 6, 2017
Start DateApril 2010
Anticipated Primary Completion DateJuly 2017
Primary Outcome Measures

Progression-free survival [Time Frame: Baseline up to 3 years]

Secondary Outcome Measures

Overall survival [Time Frame: Baseline up to 3 years]

Frequency of responses [Time Frame: Up to 3 years]

Toxicity [Time Frame: Baseline up to 3 years]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Malignant Mesothelioma
Intervention
  • Drug: pemetrexed disodium
  • Other: clinical observation
Study Arms / Comparison Groups2 / 0
Detailed Description

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.

Recruitment Information
Recruitment StatusActive, not recruiting
Actual Enrollment68
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

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

Administrative Information
NCTIDNCT01085630
Responsible Party,
SponsorAlliance for Clinical Trials in Oncology
Verification DateMarch 2017
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