Brief Title
Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
Official Title
Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-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.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-free Survival
Secondary Outcome
Overall Survival
Condition
Malignant Mesothelioma
Intervention
pemetrexed disodium
Study Arms / Comparison Groups
Arm I
Description: 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.
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
72
Start Date
April 2010
Primary Completion Date
July 2017
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Arkadiusz Dudek, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01085630
Organization ID
CALGB-30901
Secondary IDs
CALGB-30901
Responsible Party
Sponsor
Study Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Arkadiusz Dudek, MD, Study Chair, Masonic Cancer Center, University of Minnesota
Verification Date
July 2020