CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
interferon alpha +2 morebiological
Likely dose
Interferon alpha 6 million units/m² subcutaneously on days 1 and 2 weekly for 6 weeks (plus 2-week rest cycle); 13-cis-retinoic acid 1 mg/kg orally on days 1 and 2 weekly for 6 weeks; paclitaxel 75 mg/m² IV on day 2 weekly for 6 weeksAI-extracted
Key inclusion· 4
  • Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) with measurable disease
  • Age 18 years or older
  • ECOG performance status 0-3
  • Prior chemotherapy for SCLC with resolved toxicities (≤grade 1)
Key exclusion· 6
  • Prior paclitaxel or interferon therapy
  • History of other cancer except non-metastatic/non-melanoma skin cancer, cervical carcinoma in situ, or cancer cured ≥5 years prior
  • Pregnant or nursing
  • Severe depression requiring medication

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

Search/NCT00062010
NCT00062010Phase 2Completed

Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer

Eastern Cooperative Oncology Group·interventional·Posted Jun 6, 2003·Updated Jul 7, 2023

In Brief

A Phase 2 clinical trial evaluating interferon alpha, 13-cis-retinoic acid, and 1 other intervention for Lung Cancer. Completed, enrolled 37 participants across 73 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Giving interferon alfa and isotretinoin together with paclitaxel may reduce resistance to the drug and allow the tumor cells to be killed. PURPOSE: This phase II trial is studying how well giving interferon alfa and isotretinoin together with paclitaxel works in treating patients with recurrent small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2003
Enrollment StartMay 26, 2004
Primary CompletionMay 1, 2011
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 23.1 years ago

Interventions

interferon alphabiological

Interferon alpha given subcutaneously, 6 million units per square meter of body surface area on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.

13-cis-retinoic aciddrug

13-cis-retinoic acid given at 1 mg/kg of body weight by mouth on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.

paclitaxeldrug

paclitaxel administered intravenously with premedication at 75 mg/m2 of body surface area on day 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.