Clinical trial · Interventional
Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Mesothelioma | Malignant Mesothelioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clinical observation | Other | — | UNRESOLVED |
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Drug: pemetrexed disodium
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients undergo observation until disease progression.
- interventionNames
- Other: clinical observation
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- Baseline up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 disodiumReferences
Publications (0)
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