Skip to content
Triangle logo TriangleGet started
← Study library

NCT00101283 · REGISTRY CONDITION SEARCH

Pemetrexed Plus Gemcitabine or Carboplatin for Patients With Advanced Malignant Pleural Mesothelioma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2023-07-03

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating malignant pleural mesothelioma. PURPOSE: This randomized phase II trial is studying pemetrexed disodium with gemcitabine and pemetrexed disodium with carboplatin to see how well the combinations work compared to historical controls in treating patients with advanced malignant pleural mesothelioma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Best Overall Response by RECIST Criteria (Version 1.0)

→

outcome · POSTED

Overall Survival

→

outcome · POSTED

Progression-Free Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed advanced mesothelioma of the pleura * Measurable disease, as defined by RECIST criteria, within 4 weeks of randomization. Patients with pleural rinds not measurable by RECIST were eligible if disease was evaluable within 4 weeks of randomization using mesothelioma response criteria * May have undergone pleurodesis. If pleurodesis was performed, there must have been at least a 2-week delay before Pemetrexed administration. A CT must have been performed after 2 weeks after pleurodesis to serve as the baseline scan. * ECOG Performance Status of 0 or 1 * Normal organ and marrow function, as defined by: * Absolute neutrophil count ≥ 1,500/ul * Platelet count ≥ 100,000/ul * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement) * Albumin ≥ 2.5 g/dL * Creatinine clearance ≥ 45 mL/min or Creatinine ≤ 2.0 g/dL * Age 18 years and over * Able to take folic acid and cyanocobalamin (vitamin B12) * Willing and able to take dexamethasone * Women of childbearing potential and sexually active men were required to use contraception during and for the first 3 months after the study Exclusion Criteria * A candidate for curative surgery * Prior radiation therapy to the target lesion, unless the lesion was clearly progressing per RECIST criteria after prior radiation and the interval between the most recent radiation therapy and enrollment was at least 4 weeks * Prior systemic chemotherapy for mesothelioma. Prior intracavitary cytotoxic drugs or immunomodulators were not permitted, unless given for the purpose of pleurodesis. * Active infection or serious concomitant systemic disorder * Second primary malignancy, other than in situ malignancies or adequately treated basal cell carcinoma of the skin or other malignancy treated at least 3 years previously with no evidence of recurrence. * Treatment with an investigational agent within 4 weeks before enrollment * Known or suspected brain metastases * Women must not be pregnant or breastfeeding * Obviously malnourished or with a weight loss of greater than 10% in the preceding 6 weeks * Aspirin or other nonsteroidal anti-inflammatory drugs for 2 days before, during, and for 2 days after each administration of pemetrexed disodium (5 days before, during, and 2 days after each administration of pemetrexed disodium for piroxicam, naproxen, diflunisal, or nabumetone)
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to area under the curve (AUC) 5 IV over 30 minutes on day 1 of a 21-day cycle.
    intervention Names
    1. Drug: pemetrexed disodium
    2. Drug: carboplatin
    label
    Pemetrexed/Carboplatin
    type
    EXPERIMENTAL
  2. description
    Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
    intervention Names
    1. Drug: pemetrexed disodium
    2. Drug: gemcitabine hydrochloride
    label
    Pemetrexed/Gemcitabine
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Pemetrexed/Carboplatin
    2. Pemetrexed/Gemcitabine
    description
    500 mg/m2 IV over 10 minutes on day 1 of a 21-day cycle
    name
    pemetrexed disodium
    other Names
    1. Alimta
    2. MTA
    3. LY231514
    type
    DRUG
  2. arm Group Labels
    1. Pemetrexed/Gemcitabine
    description
    1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle
    name
    gemcitabine hydrochloride
    other Names
    1. Gemzar
    type
    DRUG
  3. arm Group Labels
    1. Pemetrexed/Carboplatin
    description
    Given by IV over 30 minutes at an area under the curve (AUC) of 5 on day 1 of a 21-day cycle
    name
    carboplatin
    other Names
    1. CBDCA
    2. Paraplatin
    3. JM-8
    4. NSC-241240
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
32
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression.
    measure
    Best Overall Response by RECIST Criteria (Version 1.0)
    time Frame
    Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression
secondary Outcomes
  1. description
    Time from randomization to death. Patients alive at last follow-up were censored.
    measure
    Overall Survival
    time Frame
    Assessed every 3 months for 2 years, then every 6 months for 1 year
  2. description
    Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.
    measure
    Progression-Free Survival
    time Frame
    Assessed every 3 months for 2 years, then every 6 months for 1 year
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating malignant pleural mesothelioma. PURPOSE: This randomized phase II trial is studying pemetrexed disodium with gemcitabine and pemetrexed disodium with carboplatin to see how well the combinations work compared to historical controls in treating patients with advanced malignant pleural mesothelioma.
detailed Description
OBJECTIVES: Primary * Estimate the response rates in patients with advanced malignant mesothelioma of the pleura treated with pemetrexed disodium combined with either gemcitabine or carboplatin. Secondary * Assess the toxic effects of these regimens in these patients. * Estimate survival time in patients treated with these regimens. * Correlate smoking status with outcome in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. While randomized, the study is not a comparative study. Rather, outcomes on each arm will be compared to a historical control rate from previous studies. Randomization allows simultaneous testing of two experimental arms. * Arm I: Patients receive intravenous (IV) pemetrexed disodium over 10 minutes and carboplatin IV over 30 minutes on day 1. * Arm II: Patients receive pemetrexed disodium as in arm I and gemcitabine IV over 30 minutes on days 1 and 8. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning approximately 5-10 days before the start of chemotherapy and continuing until approximately 3 weeks after completion of chemotherapy, all patients receive oral folic acid once daily and cyanocobalamin (vitamin B12) intramuscularly every 9 weeks. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 32-60 patients (16-30 per treatment arm) will be accrued for this study within 12.8-27.0 months.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-499e82a3e52478e32c2e
      requested nct id
      NCT00101283
      primary nct id
      NCT00101283
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      0a018dbf1aa46f57978b6d16aa19b94d76d6d65cf1e297e889c8e599fef1fab1
      payload sha256
      a9a46b40266bb2a7bc93aeb117029122f2674ba0aa0a95f1db453ce4730c558e
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-499e82a3e52478e32c2e
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00101283
      occurrences
      1. context exact
        NCT00101283
        end
        11
        exact text
        NCT00101283
        start
        0
      offset unit
      unicode_code_points
      query cond
      Malignant Mesothelioma
      query disease state id
      ds-malignant-mesothelioma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-malignant-mesothelioma-000.json
      source file sha256
      0a018dbf1aa46f57978b6d16aa19b94d76d6d65cf1e297e889c8e599fef1fab1
      source json pointer
      /studies/93/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      efb6351a7bf6926fdd7e48998841194db4b8a1bdcac5f92a405ce921a87bd6a2

    Preserved source evidence · Not medical advice