A Randomized Phase II Study: Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer (SCLC): Topotecan Sequenced With Etoposide/Cisplatin, and Irinotecan/Cisplatin Sequenced With Etoposide

NCT00057837 Phase 2 COMPLETED Results posted

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.

Details

Lead sponsor	Eastern Cooperative Oncology Group
Phase	Phase 2
Status	COMPLETED
Enrolment	140
Start date	2004-07-14
Completion	2012-08

Conditions

• Extensive Stage Small Cell Lung Cancer

Interventions

• G-CSF
• Cisplatin
• Etoposide
• Irinotecan
• Topotecan

Primary outcomes

• Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST) — Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.
  Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR

Countries

United States