CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
carboplatin +2 moredrug
Likely dose
Neoadjuvant: carboplatin AUC 6 IV Day 1 and paclitaxel 175 mg/m² IV Day 1, both q 21 days × 3 cycles; post-surgery: carboplatin AUC 5 IP Day 1 and paclitaxel 175 mg/m² IV Day 1 plus 60 mg/m² IP Day 8, both q 28 days × 6 cyclesAI-extracted
Key inclusion· 4
  • ✓Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer with adenocarcinoma
  • ✓Large pelvic mass and/or bulky abdominal disease and/or malignant pleural effusion (pleural effusion only allowed for stage IV)
  • ✓Optimal cytoreduction clinically deemed unlikely
  • ✓CA 125 at least 70 units/mL
Key exclusion· 10
  • ✕Borderline or low-malignant potential tumors
  • ✕Parenchymal, liver, lung, or other distant metastases (except pleural effusion for stage IV)
  • ✕Prior chemotherapy for this cancer
  • ✕Prior pelvic radiation for this cancer

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

Search/NCT00008138
NCT00008138Phase 2Completed
CompareCT.gov

Phase II Evaluation Of Neoadjuvant Chemotherapy, Interval Debulking Followed By Intraperitoneal Chemotherapy In Women With Stage III And IV Epithelial Ovarian Cancer, Fallopian Tube Cancer Or Primary Peritoneal Cancer

SWOG Cancer Research Network·interventional·Posted Jan 27, 2003·Updated Jan 8, 2016

In Brief

A Phase 2 clinical trial evaluating carboplatin, paclitaxel, and 1 other intervention for Fallopian Tube Cancer and 2 related conditions. Completed, enrolled 62 participants.

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 drug or combining chemotherapy with surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in treating patients who have stage III or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMar 1, 2001
Primary CompletionSep 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 23.4 years ago

Interventions

carboplatindrug

pre-surgery - target AUC=6, Day 1 IV, q 21 days X 3 cycles post-surgery - target AUC=5, Day 1 IP, q 28 days X 6 cycles

paclitaxeldrug

pre-surgery - 175 mg/m2 IV Day 1, q 21 days X 3 cycles post-surgery - 175 mg/m2 IV Day 1, q 28 days X 6 cycles AND 60 mg/m2 IP Day 8, q 28 days X 6 cycles

debulking surgeryprocedure

exploratory laparotomy, interval cytoreduction (to \< 1 cm residual)