Tirapazamine Combined With Chemo and RT in Limited-Stage Small Cell Lung Cancer
Condition: Limited Stage Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: tirapazamine; cisplatin; etoposide; radiation therapy; laboratory biomarker analysis
Intervention description: Given IV; Given IV; Given IV; Undergo radiation therapy; Correlative studies
Intervention MeSH terms: Etoposide; Etoposide phosphate; Tirapazamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving tirapazamine together with cisplatin,
      etoposide, and radiation therapy works in treating patients with limited-stage small cell
      lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different
      ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses
      high-energy x-rays to damage tumor cells. Tirapazamine may make the tumor cells more
      sensitive to chemotherapy and radiation therapy. Combining chemotherapy and radiation therapy
      with tirapazamine may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed diagnosis of limited
             small cell lung cancer; diagnosis on the basis of sputum cytology is acceptable if
             confirmation by an independent pathologic review at the institution is documented

          -  Patients must have measurable OR non-measurable disease documented by CT, MRI or
             X-ray; any scan abnormalities, which may otherwise represent metastatic disease,
             should be confirmed benign by appropriate tests and documented on the baseline tumor
             assessment form (form #848); if an abnormality is present at baseline, it is assumed
             to be disease involvement unless proven otherwise; disease must be assessed within 28
             days prior to registration for measurable disease and 42 days prior to registration
             for non-measurable disease; NOTE: The use of PET scans for tumor imaging is not
             allowed

          -  Patients with any brain metastases are ineligible; all patients must have a
             pretreatment CT or MRI scan of the brain to evaluate CNS disease within 42 days prior
             to registration

          -  Patients with malignant pericardial effusions OR malignant pleural effusions are
             ineligible; these are defined as either cytologically positive effusions OR exudative
             effusions not attributable to other etiologies; patients with effusions too small to
             tap are eligible

          -  Patients must have a measured or calculated creatinine clearance >= 50 cc/min obtained
             within 28 days prior to registration; serum creatinine is only necessary if calculated
             CrCl is used; if calculated CrCl is used, serum creatinine must be < 1.5 mg/dl

          -  ANC >= 1,500/ul obtained within 28 days prior to registration

          -  Platelet count >= 100,000/ul obtained within 28 days prior to registration

          -  Serum bilirubin =< 1.5 x the institutional upper limit of normal within 28 days prior
             to registration

          -  SGOT or SGPT =< 2 x the institutional upper limit of normal within 28 days prior to
             registration

          -  All patients must have a Zubrod performance status of 0-1

          -  Patients must not have received previous chemotherapy or biologic therapy for small
             cell lung cancer; patients must not have received prior thoracic or neck radiation for
             any reason

          -  At least two weeks must have elapsed since surgery (thoracic or other major surgeries)
             and patients must have recovered from all associated toxicities; measurable or
             non-measurable disease must be present outside the area of surgical resection

          -  Patients with significant clinical hearing loss must be willing to accept the
             potential for worsening of symptoms

          -  Patients must not have >= grade 1 symptomatic neuropathy-sensory (NCI Common
             Terminology Criteria for Adverse Events version 3.0)

          -  Patients must have a pre-registration FEV1 and DLCO obtained within 28 days prior to
             registration

          -  Institutions must have received IRB approval of S9925 (the Lung Cancer Specimen
             Repository); patients must be offered participation in S9925; with the patient's
             consent, plasma, serum and tissue will be submitted for testing via S9925; patients
             must be registered separately to S9925 to receive credit for specimen submission

          -  The radiation oncology facility must be willing to deliver 3D conformal radiation; if
             the radiation therapy is to be done at a different institution, then the institution
             name and ID must be provided; the radiation therapy facility must be SWOG-approved;
             NOTE: The radiation oncology facility must have successfully completed the benchmark
             material from the Quality Assurance Review Center (QARC) or be willing to complete the
             benchmark material prior to submission of the final radiation forms due within 30 days
             of completing radiation therapy

          -  No prior malignancy is allowed except for the following: adequately treated basal cell
             or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or
             II cancer from which the patient is currently in complete remission, or any other
             cancer from which the patient has been disease-free for at least 5 years

          -  If day 28 or 42 falls on a weekend of holiday, the limit may be extended to the next
             working day; in calculating days of tests and measurements, the day a test or
             measurement is done is considered day 0; therefore, if a test is done on a Monday, the
             Monday four weeks later would be considered day 28; this allows for efficient patient
             scheduling without exceeding the guidelines

          -  Pregnant or nursing women may not participate in this trial because of the increased
             risk of fetal harm including fetal death from the chemotherapeutic agents; women of
             reproductive potential must have agreed to use an effective contraceptive method

          -  All patients must be informed of the investigational nature of this study and must
             sign and give written informed consent in accordance with institutional and federal
             guidelines

          -  At the times of patient registration, the treating institution's name and ID number
             must be provided to the Data Operation Center in Seattle in order to ensure that the
             current (within 365 days) date of institutional review board approval for this study
             has been entered into the database