CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
tirapazamine +4 moredrug
Likely dose
Tirapazamine IV, cisplatin IV, etoposide IV (specific doses not stated in arms/interventions)AI-extracted
Key inclusion· 9
  • Histologically or cytologically confirmed limited-stage small cell lung cancer
  • Measurable or non-measurable disease documented by CT, MRI, or X-ray within 28 days (measurable) or 42 days (non-measurable) prior to registration
  • Creatinine clearance ≥50 cc/min or serum creatinine <1.5 mg/dL if calculated CrCl used, within 28 days prior to registration
  • ANC ≥1,500/μL within 28 days prior to registration
Key exclusion· 6
  • Any brain metastases; brain CT or MRI required within 42 days prior to registration
  • Malignant pericardial or pleural effusions (cytologically positive or exudative not attributable to other etiologies)
  • Prior chemotherapy or biologic therapy for small cell lung cancer
  • Prior thoracic or neck radiation for any reason

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00066742
NCT00066742Phase 2Completed

A Phase II Study of Tirapazamine (NSC-130181)/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer

National Cancer Institute (NCI)·interventional·Posted Aug 7, 2003·Updated May 15, 2014

In Brief

A Phase 2 clinical trial evaluating tirapazamine, cisplatin, and 3 other interventions for Limited Stage Small Cell Lung Cancer. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2003
Enrollment StartSep 1, 2003
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 22.9 years ago

Interventions

tirapazaminedrug

Given IV

cisplatindrug

Given IV

etoposidedrug

Given IV

radiation therapyradiation

Undergo radiation therapy

laboratory biomarker analysisother

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