CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
cisplatin +2 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
  • ✓Tumor involves one or both ovaries with microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node metastasis
  • ✓Optimally debulked with no residual lesions or residual disease <1 cm
  • ✓Staging exploratory laparotomy with tumor debulking within past 70 days
Key exclusion· 8
  • ✕Borderline or low malignant potential tumors only
  • ✕Grade 2 or greater sensory neuropathy
  • ✕Severe gastrointestinal symptoms (partial obstruction, bleeding, diarrhea, or abdominal tenderness suggestive of peritoneal irritation/infection)
  • ✕Erythema or tenderness of abdominal incision/port site suggestive of infection

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

Search/NCT00003896
NCT00003896Phase 2Completed
CompareCT.gov

Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer

SWOG Cancer Research Network·interventional·Posted Jan 27, 2003·Updated Jan 4, 2013

In Brief

A Phase 2 clinical trial evaluating cisplatin, liposomal doxorubicin, and 1 other intervention for Fallopian Tube Cancer and 2 related conditions. Completed, enrolled 68 participants across 104 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, cisplatin, and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartSep 1, 1999
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 23.4 years ago

Interventions

cisplatindrug

liposomal doxorubicindrug

paclitaxeldrug