Trial Search Results

Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy

The purpose of this trial is to study how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: pemetrexed disodium
  • Other: clinical observation

Phase:

Phase 2

Eligibility


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 disodium

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting