CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 140 enrolled
Drug / intervention
G-CSF +4 morebiological
Likely dose
Arm PET: Topotecan 0.75 mg/m2 IV on days 1–3, followed by Etoposide 70 mg/m2 IV on days 8–10 and Cisplatin 20 mg/m2 IV on days 8–10; Arm PIE: Irinotecan 50 mg/m2 IV on days 1 and 8, followed by Etoposide 85 mg/m2 orally on days 3 and 10, and Cisplatin 20 mg/m2 IV on days 1 and 8AI-extracted
Key inclusion· 8
  • ✓Extensive stage SCLC with measurable disease, evaluated within 2 weeks prior to randomization
  • ✓ECOG performance status 0-3
  • ✓Age 18 and older
  • ✓If prior second malignancy (other than treated basal/squamous cell skin cancer or cervical carcinoma in situ), must be disease-free for ≥5 years
Key exclusion· 3
  • ✕Prior chemotherapy for lung cancer
  • ✕Prior radiotherapy for lung cancer (except CNS radiotherapy for CNS metastases)
  • ✕Pregnant or lactating

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

Search/NCT00057837
NCT00057837Phase 2Completed
CompareCT.gov

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

Eastern Cooperative Oncology Group·interventional·Posted Apr 9, 2003·Updated Jul 5, 2023

In Brief

A Phase 2 clinical trial evaluating G-CSF, Cisplatin, and 3 other interventions for Extensive Stage Small Cell Lung Cancer. Completed, enrolled 140 participants across 79 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExtensive Stage Small Cell Lung Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2003
Enrollment StartJul 14, 2004
Primary CompletionJan 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 23.2 years ago

Interventions

G-CSFbiological

G-CSF will be administered subcutaneously at a dose of 5 mcg/kg once a day starting on day 11 until WBC recovery \> 10,000 dL.

Cisplatindrug

Arm PET: 20 mg/m2 IV on days 8, 9 and 10 of each cycle following Etoposide. Arm PIE: 20 mg/m2 IV on days 1 and 8 of each cycle following Irinotecan.

Etoposidedrug

Arm PET: 70 mg/m2 IV over 60 minutes on days 8, 9 and 10 of each cycle. Arm PIE: 85 mg/m2 orally (divided into 2 doses, 12 hours apart) on day 3 and 10 of each cycle.

Irinotecandrug

50 mg/m2 IV over 90 minutes on days 1 and 8 of each cycle (Arm PIE only).

Topotecandrug

Topotecan 0.75 mg/m2 IV over 30 minutes on days 1,2 and 3 of each cycle (Arm PET only).