CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
carboplatin +1 moredrug
Likely dose
Carboplatin AUC 6.0 IV on day 1 + paclitaxel 225 mg/m² IV on day 1 of 21-day cycle, up to 6 cyclesAI-extracted
Key inclusion· 8
  • Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic carcinoma not amenable to curative surgery
  • Extensive disease (distant, pleural, pulmonary with/without mediastinal, or recurrent progressive disease in prior radiotherapy site)
  • Measurable disease required
  • Age 18 years or older
Key exclusion· 3
  • Acute concurrent complications (infection, post-surgical complications)
  • Other prior malignancy within past 5 years unless curatively treated with no recurrence
  • Prior chemotherapy for metastatic disease (prior neoadjuvant/adjuvant allowed if >1 year disease-free interval)

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

Search/NCT00010257
NCT00010257Phase 2Completed

Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma

Eastern Cooperative Oncology Group·interventional·Posted Jan 27, 2003·Updated Jun 29, 2023

In Brief

A Phase 2 clinical trial evaluating carboplatin and paclitaxel for Thymoma and Thymic Carcinoma. Completed, enrolled 46 participants across 67 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 chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.

Study Details

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

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJun 19, 2001
Primary CompletionNov 1, 2008
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 23.4 years ago

Interventions

carboplatindrug

Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles

paclitaxeldrug

225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles