Clinical trial · Interventional
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
NCT00003896CI-TRIAL-00008786completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| liposomal doxorubicin | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel/cisplatin/Liposomal Doxorubicin
- description
- paclitaxel, cisplatin and liposomal doxorubicin
- interventionNames
- Drug: cisplatin
- Drug: liposomal doxorubicin
- Drug: paclitaxel
Primary outcomes (2)
- measure
- Progression-free Survival
- timeFrame
- Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.
- description
- From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.
- measure
- Overall Survival
- timeFrame
- Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * 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 * No tumors of borderline or low malignant potential only * Mixed Mullerian tumors allowed * Must have optimal disease defined as no residual lesions after resection or residual disease such that no single lesion measures greater than 1 cm in diameter * Must have undergone staging exploratory laparotomy with tumor debulking within the past 70 days PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * SWOG 0-1 Life expectancy: * Not specified Hematopoietic: * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic: * Bilirubin ≤ 2 times upper limit of normal (ULN) * SGOT or SGPT ≤ 2 times ULN Renal: * Creatinine clearance ≥ 50 mL/min Cardiovascular: * No congestive heart failure * No cardiac arrhythmia * No myocardial infarction or unstable angina within the past 6 months * Patients with a history of myocardial disease must not have ischemia or pathologic arrhythmias and must have an ejection fraction \> 50% by MUGA Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No active or uncontrolled infection * No concurrent fever * No grade 2 or greater sensory neuropathy * No severe gastrointestinal symptoms (i.e., partial obstruction) and/or bleeding, diarrhea, or abdominal tenderness suggestive of peritoneal irritation or infection * No erythema or tenderness of abdominal incision or port site suggestive of underlying infection * No other malignancy within the past five years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy for ovarian cancer Chemotherapy: * No prior chemotherapy for ovarian cancer Endocrine therapy: * Not specified Radiotherapy: * No prior pelvic radiotherapy for ovarian cancer Surgery: * See Disease Characteristics * Recovered from all reversible surgery-related toxic effects Other: * No other concurrent antitumor treatment * No concurrent antibiotics for infection of undetermined etiology
References
Publications (1)
- RESULTSmith HO, Moon J, Wilczynski SP, Tiersten AD, Hannigan EV, Robinson WR, Rivkin SE, Anderson GL, Liu PY, Markman M. Southwest Oncology Group Trial S9912: intraperitoneal cisplatin and paclitaxel plus intravenous paclitaxel and pegylated liposomal doxorubicin as primary chemotherapy of small-volume residual stage III ovarian cancer. Gynecol Oncol. 2009 Aug;114(2):206-9. doi: 10.1016/j.ygyno.2009.04.023. Epub 2009 May 23. PMID 19464730