At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 55 enrolled
Drug / intervention
carboplatin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
- ✓Histologically confirmed uterine carcinosarcoma (mixed mesodermal tumor)
- ✓Stage III or IV disease
- ✓Persistent or recurrent disease with documented disease progression
- ✓Measurable disease: ≥1 lesion ≥20 mm by conventional imaging or ≥10 mm by spiral CT
Key exclusion· 6
- ✕Prior cytotoxic chemotherapy for uterine sarcoma
- ✕Other invasive malignancy within the past 5 years (except nonmelanoma skin cancer)
- ✕Sensory or motor neuropathy greater than grade 1
- ✕Active infection requiring antibiotics
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Evaluation of Paclitaxel (Taxol, NSC # 673089) and Carboplatin (Paraplatin, NSC #241240) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma
In Brief
A Phase 2 clinical trial evaluating carboplatin and paclitaxel for Sarcoma. Completed, enrolled 55 participants across 110 sites in 2 countries.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma
CountriesJapan, United States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2005
First PostedJun 2005
Primary CompletionJul 2010
TodayJul 2026
First PostedJun 3, 2005
Enrollment StartMay 1, 2005
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 21.1 years ago
Interventions
carboplatindrug
paclitaxeldrug