Tirapazamine Combined With Chemo and RT in Limited-Stage Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Limited Stage Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00066742

Run by

National Cancer Institute (NCI)

People needed

72

Starts

2003-09-01

Expected to finish

2009-08-01

Last updated by the study team

2014-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Southwest Oncology Group (SWOG) Research Base — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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