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ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Mesothelioma

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Trial Information

ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial


OBJECTIVES:

- Determine the objective tumor response rate in chemotherapy-naïve patients with
malignant pleural mesothelioma treated with pemetrexed disodium and gemcitabine.

- Determine the median survival of patients with malignant pleural or peritoneal
mesothelioma treated with this regimen.

- Determine the time to objective tumor response and duration of response in patients
treated with this regimen.

- Determine the time to treatment failure in patients treated with this regimen.

- Determine the time to progressive disease in patients treated with this regimen.

- Determine the progression-free and overall survival of patients treated with this
regimen.

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

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

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and pemetrexed disodium IV
over 8-15 minutes on day 8. Treatment repeats every 21 days for at least 6 courses in the
absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 3 months.

PROJECTED ACCRUAL: A total of 18-73 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed malignant pleural or peritoneal mesothelioma of 1 of the
following subtypes:

- Epithelial

- Sarcomatoid

- Mixed subtype

- Disease not amenable to curative surgery

- Measurable disease

- At least 1 measurable lesion at least 20 mm by conventional techniques or at
least 10 mm by spiral CT scan

- At least 1 level on lesion scan must have 1 pleural rind measurement at least 15
mm

- If there is only 1 measurable lesion, the neoplastic nature must be
histologically confirmed

- Clinically detected lesions are only considered measurable if superficial (e.g.,
skin nodules and palpable lymph nodes)

- The following are not considered measurable disease:

- Pleural effusions

- Positive bone scans

- No known or suspected brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

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 times ULN*

- ALT and AST no greater than 3 times ULN*

- Albumin at least 2.5 g/dL NOTE: *No greater than 5 times ULN in the case of liver
involvement by tumor

Renal

- Creatinine clearance at least 45 mL/min

Other

- Not pregnant or nursing

- Negative pregnancy test

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

- No active infection

- No concurrent serious systemic disorders (including oncologic emergencies) that would
preclude study participation

- No other currently active malignancy except nonmelanoma skin cancer or carcinoma in
situ of the cervix (patients with previously treated malignancy are eligible if at
less than 30% risk of relapse)

- Able to tolerate folic acid or cyanocobalamin administration

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior intracavitary immunomodulators, unless given for pleurodesis

- No filgrastim (G-CSF) within 24 hours of study chemotherapy administration

- No concurrent immunotherapy

- No concurrent routine colony-stimulating factor therapy

- No concurrent stimulators of thrombopoiesis

Chemotherapy

- No prior systemic chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent hormonal therapy for cancer

Radiotherapy

- Prior radiotherapy to the target lesion allowed provided the lesion has clearly
progressed

- At least 4 weeks since prior radiotherapy

- No concurrent non-palliative radiotherapy

Surgery

- No concurrent surgery for cancer

Other

- At least 2 weeks since prior pleurodesis

- No prior intracavitary cytotoxic drugs, unless given for pleurodesis

- More than 4 weeks since prior investigational agents

- No aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 days of
pemetrexed disodium administration

- No long-acting NSAIDs (e.g., naproxen, piroxicam, diflunisal, nabumetone,
rofecoxib, or celecoxib) within 5 days of pemetrexed disodium administration

- No other concurrent experimental medications (except thymidine)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Afshin Dowlati, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000299535

NCT ID:

NCT00060190

Start Date:

February 2003

Completion Date:

Related Keywords:

  • Malignant Mesothelioma
  • advanced malignant mesothelioma
  • epithelial mesothelioma
  • sarcomatous mesothelioma
  • Mesothelioma

Name

Location

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106