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Malignant MesotheliomaPhase 2NCT00354393

Combination Chemotherapy With or Without Surgery & Chemoradiotherapy in Patients With Malignant Pleural Mesothelioma

A Phase 2 study testing Cisplatin, Methotrexate and Vinorelbine ditartrate in people with Malignant Mesothelioma, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinorelbine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages Up to 75 years
Conditions the study is for
Malignant Mesothelioma
What is being tested?
Cisplatin, Methotrexate and Vinorelbine ditartrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
Aug 2002to Jun 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant pleural mesothelioma
  • Amenable to aggressive surgical resection, if deemed resectable
  • Patients with potentially resectable disease must have undergone mediastinoscopy to establish surgical stage
  • Resectable disease is defined as any of the following:
  • Epithelioid, mixed histology, or histology not otherwise specified with clinical stage I-III (T1-3, N0-2, M0) disease
  • Sarcomatoid histology with clinical stage I-III (T1-3, N0) disease
  • Intraperitoneal extension, contralateral thoracic extension, or distant metastases are eligible, but considered unresectable
  • Disease considered unresectable by any medical reason or if surgery was declined

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • WBC ≥ 3,000/mm³
  • Platelet count > 100,000/mm³
  • Creatinine ≤ 1.7 mg/dL
  • Alkaline phosphatase < 2 times normal
  • AST < 2 times normal
  • Albumin > 3 g/dL
  • Bilirubin < 2.0 mg/dL
  • Patients must be available for and compliant with adequate long-term follow-up
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Patients with resectable disease must have adequate pulmonary function to undergo surgery and radiotherapy
  • No other active malignancies

PRIOR CONCURRENT THERAPY:

  • No prior surgical resection, radiation therapy, chemotherapy, or immunotherapy for this cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

Other trials in United States

About this study

Official title: Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma

RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinorelbine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin may also make tumor cells more sensitive to radiation therapy. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without surgery and chemoradiotherapy works in treating patients with malignant pleural mesothelioma.

Read the detailed description

OBJECTIVES:

Primary

  • Assess the response to induction combination chemotherapy comprising methotrexate, vinorelbine ditartrate, and cisplatin in patients with previously untreated malignant pleural mesothelioma.

Secondary

  • Assess the tolerability and toxicity of this regimen in these patients.
  • Determine relapse-free and overall survival of patients treated with induction combination chemotherapy with or without surgery and hemithoracic radiation.
  • Assess the impact of induction combination chemotherapy on operability and surgical success.
  • Evaluate the impact of these treatment regimens on quality of life.

OUTLINE:

  • Induction chemotherapy: Patients receive MVP chemotherapy comprising cisplatin IV over 30-60 minutes on day 1 and vinorelbine ditartrate IV over 5-10 minutes and methotrexate IV over 5-30 minutes on days 8, 15, and 22. Treatment repeats every 28 days for 2 courses. Patients with unresectable disease may receive up to 2 additional courses of induction chemotherapy. Patients requiring palliative radiotherapy or who have progressive disease are removed from the study. Patients with resectable disease or sarcomatoid histology and T1-3, N1-2 disease with a complete or partial response to induction chemotherapy proceed to surgery.
  • Surgery: Patients with extensive disease undergo palliative debulking pleurectomy and decortication and then are taken off study. All other patients undergo a thoracotomy with an extrapleural pneumonectomy and then proceed to chemoradiotherapy.
  • Chemoradiotherapy: Beginning 6-10 weeks after surgery, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients also receive cisplatin IV over 30-60 minutes on days 1 and 22. Patients with responding disease proceed to adjuvant chemotherapy.
  • Adjuvant chemotherapy: Patients receive 2 additional courses of MVP chemotherapy as above.

Quality of life is assessed at baseline, after each course of induction chemotherapy, before surgery, and then every 3 months thereafter.

After completion of study therapy, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Being tested
Cisplatin, Methotrexate, Vinorelbine ditartrate, Adjuvant therapy, Conventional surgery
Keywords
localized malignant mesothelioma, sarcomatous mesothelioma, advanced malignant mesothelioma, epithelial mesothelioma
Medical subject headings
Mesothelioma, Malignant, Solitary Fibrous Tumor, Pleural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00354393
Study groupRoleWhat they receive
Induction Combination ChemotherapyExperimentalInduction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses. Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology \& T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery. Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication \& are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy \& proceed to chemoradiotherapy. Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 \& 22. Patients w/ responding disease proceed to adjuvant chemotherapy. Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy
Receives: Drug: Cisplatin; Drug: Methotrexate; Drug: Vinorelbine ditartrate; Procedure: Adjuvant therapy; Procedure: Conventional surgery; Procedure: Neoadjuvant Therapy; Radiation: 3-dimensional conformal radiation therapy; Radiation: Intensity-modulated radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Response

    Best response to chemotherapy after induction

    Measured: After 2-4 cycles of induction chemotherapy (28 day cycle)

Secondary outcomes (3)

  1. Tolerability and toxicity

    Toxicity related to induction chemotherapy

    Measured: After 2-4 cycles of induction chemotherapy (28 day cycle)

  2. Relapse free and overall survival

    Time to relapse and overall survival

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first

  3. Assess Patient Quality of Life

    Patient Quality of Life during induction chemotherapy

    Measured: Prior to initiation of each cycle of therapy, and every 3 months after completion of therapy until death, withdrawal or loss to follow up (Average 10 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2006 (estimated)
  2. Study startAug 2002
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00354393
Sponsor's protocol ID
CASE-CCF-IRB-5179
Other IDs
P30CA043703, CASE-CCF-IRB-5179
Status last verified
Jul 2025
First submitted
19 Jul 2006
Last updated
15 Jul 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Shared on Physician Data Query

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, Methotrexate and Vinorelbine ditartrate in people with Malignant Mesothelioma, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Response (time frame: After 2-4 cycles of induction chemotherapy (28 day cycle)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00354393.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.

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