Trials / Completed
CompletedNCT00003896
S9912 Combination Chemo in Stage III Ovarian Cancer,
Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- SWOG Cancer Research Network · Network
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
OBJECTIVES: * Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or primary peritoneal cancer. * Determine the feasibility of and toxic effects associated with this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over 30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cisplatin | |
| DRUG | liposomal doxorubicin | |
| DRUG | paclitaxel |
Timeline
- Start date
- 1999-09-01
- Primary completion
- 2008-02-01
- Completion
- 2008-02-01
- First posted
- 2003-01-27
- Last updated
- 2013-01-04
- Results posted
- 2012-11-29
Locations
104 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00003896. Inclusion in this directory is not an endorsement.