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A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Mesothelioma

Thank you

Trial Information

A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma


OBJECTIVES:

Primary

- Determine the pathological complete response rate in patients with stage I, II, or III
pleural mesothelioma treated with neoadjuvant pemetrexed disodium and cisplatin
followed by extrapleural pneumonectomy and radiotherapy.

Secondary

- Determine the 1- and 2-year disease-free and median survival of patients treated with
this regimen.

- Determine the clinical response rate by radiological assessment in patients treated
with this regimen.

- Determine the quantitative and qualitative toxic effects of this regimen in these
patients.

- Determine the pattern of relapse (local vs metastatic) in patients treated with this
regimen.

- Determine the time to event efficacy variables (i.e., time to objective tumor response,
time to treatment failure, time to progressive disease, and overall survival) in
patients treated with this regimen.

- Correlate response to treatment with this regimen with levels of TS, DHFR, GARFT, FPGS,
DPD, RFCI, alpha-FR, and ERCC1 in the mesothelioma tissue of these patients.

OUTLINE: This is an open-label, multicenter study.

- Preoperative chemotherapy: Patients receive pemetrexed disodium IV over 10 minutes and
cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity.

- Extrapleural pneumonectomy: Patients undergo extrapleural pneumonectomy within 3-8
weeks after the last course of chemotherapy.

- Hemi-thoracic radiotherapy: Beginning 4-8 weeks after surgery, patients undergo
radiotherapy to the chest once daily 5 days a week for 6 weeks.

Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 77 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed pleural mesothelioma

- Stage I, II, or III (T1-3, N0-2, M0)

- No cardiac involvement

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 3.0 times ULN

- AST and ALT no greater than 3.0 times ULN

Renal

- Creatinine clearance at least 45 mL/min

Cardiovascular

- See Disease Characteristics

- Cardiac function adequate by radionuclide stress test, exercise stress test to
maximal exercise level, or stress echocardiogram

Pulmonary

- FEV_1 at least 2 L OR at least 35% of predicted postoperative (ppoFEV_1)

- DLCO greater than 35% of ppoFEV_1

- PCO_2 less than 50 on ABG

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

- Able and willing to take folic acid, cyanocobalamin, or dexamethasone

- Willing to have cytoreduction by extrapleural pneumonectomy

- No active infection

- Suitable candidate for this study therapy

- No concurrent serious systemic disorder (e.g., active infection) that would
compromise the patient's safety or ability to complete the study

- No other primary malignancy except carcinoma in situ of the cervix, adequately
treated nonmelanoma skin cancer, low-grade (Gleason score no greater than 6)
localized adenocarcinoma of the prostate, or other malignancy curatively treated
within the past 2 years with no evidence of recurrence

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior immunotherapy or biologic therapy

- No prior intracavity immunomodulators (chemical pleurodesis allowed)

- No concurrent immunotherapy or biologic therapy

- No concurrent routine filgrastim (G-CSF)

- No concurrent stimulator of thrombopoiesis

Chemotherapy

- No prior systemic chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent anticancer hormonal therapy

Radiotherapy

- No prior radiotherapy

- No concurrent radiotherapy

Surgery

- No prior surgical resection of mesothelioma

- Prior chemical pleurodesis allowed

- No concurrent anticancer surgery

Other

- More than 30 days since prior drug not approved for any indication

- No prior intracavity cytotoxic drugs (chemical pleurodesis allowed)

- No prior participation in this study or any other study investigating pemetrexed
disodium

- No other concurrent experimental medication (thymidine allowed)

- No other concurrent anticancer therapy

- No nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates 2 days before, the
day of, or 2 days after study therapy

- No NSAIDs or salicylates with a long half-life (e.g., piroxicam or nabumetone) 5
days before, the day of, or 2 days after study therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response rate

Safety Issue:

No

Principal Investigator

Lee M. Krug, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000339681

NCT ID:

NCT00072397

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Malignant Mesothelioma
  • localized malignant mesothelioma
  • Mesothelioma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115