CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Paclitaxel +1 moredrug
Likely dose
Paclitaxel and oxaliplatin given intravenously (specific doses not stated)AI-extracted
Key inclusion· 6
  • ✓Histologically or cytologically confirmed squamous cell, adenosquamous cell, or adenocarcinoma of the cervix
  • ✓Metastatic disease outside the pelvis OR locally recurrent disease in the pelvis with ≥50% size increase on imaging
  • ✓Measurable disease: ≥20 mm on conventional imaging or ≥10 mm on spiral CT
  • ✓Prior chemotherapy allowed only if given with primary radiation therapy; none allowed for advanced/recurrent disease
Key exclusion· 7
  • ✕Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas/mitomycin C) prior to study entry
  • ✕Brain metastases
  • ✕History of allergic reactions to platinum agents (cisplatin, carboplatin, oxaliplatin) or taxanes (paclitaxel, docetaxel)
  • ✕Uncontrolled intercurrent illness (active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, psychiatric illness)

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

Search/NCT00057863
NCT00057863Phase 2Completed
CompareCT.gov

A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Cervical Cancer

National Cancer Institute (NCI)·interventional·Posted Apr 9, 2003·Updated Nov 17, 2015

In Brief

A Phase 2 clinical trial evaluating Paclitaxel and Oxaliplatin for Cervical Adenocarcinoma and 5 related conditions. Completed, enrolled 35 participants across 1 site.

Detailed Summary

Phase II trial to study the effectiveness of combining oxaliplatin with paclitaxel in treating patients who have locally recurrent or metastatic cervical cancer. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Recurrent Cervical Carcinoma, Stage IVA Cervical Cancer, Stage IVB Cervical Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2003
Enrollment StartJan 1, 2003
Primary CompletionDec 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 23.2 years ago

Interventions

Paclitaxeldrug

Given IV

Oxaliplatindrug

Given IV