CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 186 enrolled
Drug / intervention
carboxyamidotriazole +3 moredrug
Likely dose
carboxyamidotriazole orally (specific dose not stated)AI-extracted
Key inclusion· 6
  • Histologically or cytologically confirmed NSCLC stage III or IV
  • Disease stable or responding after standard chemotherapy (with or without TRT) for 3-6 months (TRACK I) or responsive after 3-6 months chemo (TRACK II at randomization)
  • Exactly one prior chemotherapy regimen for NSCLC (radiosensitizers allowed)
  • ≤6 weeks from last chemotherapy or radiation dose
Key exclusion· 4
  • Untreated brain metastases
  • Pregnant or nursing women; females/sexual partners of childbearing potential without adequate contraception during treatment and 2 months after discontinuation
  • Concomitant participation in another phase III lung cancer treatment trial (TRACK I only)
  • Planned concurrent chemotherapy, immunotherapy, or radiotherapy

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

Search/NCT00003869
NCT00003869Phase 3Completed

Phase III Randomized, Double-Blind Study of CAI and Placebo in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

National Cancer Institute (NCI)·interventional·Posted Jan 27, 2003·Updated May 20, 2014

In Brief

A Phase 3 clinical trial evaluating carboxyamidotriazole, placebo, and 2 other interventions for Stage IIIA Non-small Cell Lung Cancer and 2 related conditions. Completed, enrolled 186 participants across 1 site.

Detailed Summary

Randomized phase III trial to determine the effectiveness of carboxyamidotriazole in treating patients who have stage III or stage IV non-small cell lung cancer. Chemotherapeutic agents are modestly effective for the treatment of advanced lung cancer, with rapid tumor relapse and growth even after initial response to therapy. It is not yet known whether carboxyamidotriazole is more effective than no further treatment after standard chemotherapy for non-small cell lung cancer.

Study Details

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

Timeline

Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartApr 1, 1999
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 23.4 years ago

Interventions

carboxyamidotriazoledrug

Given PO

placeboother

Given PO

quality-of-life assessmentprocedure

Ancillary studies

laboratory biomarker analysisother

Correlative studies