Clinical trial · Interventional
Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
A Phase III Study of Cisplatin Plus Topotecan Followed by Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Women With Newly Diagnosed Advanced Epithelial Ovarian Cancer
NCT00028743CI-TRIAL-00044403completedPhase 3ClinicalTrials.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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial cancer , primary peritoneal cancer, or fallopian tube 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cisplatin, Topotecan, Paclitaxel plus Carboplatin
- description
- Arm 1
- interventionNames
- Drug: carboplatin
- Drug: cisplatin
- Drug: paclitaxel
- Drug: topotecan hydrochloride
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel plus Carboplatin
- description
- Arm 2
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer * No borderline ovarian tumors * Residual disease allowed * Fine needle aspiration showing an adenocarcinoma is allowed instead of open or true-cut biopsy if the following are true: * Presence of pelvic mass AND * Omental cake or other metastasis larger than 2 cm in the upper abdomen unless proven stage IV disease AND * Serum CA 125/carcinoembryonic antigen ratio at least 25 (if less than 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for primary tumor within 6 weeks of study) AND * Normal mammography within 6 weeks of study PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * ECOG 0-1 Life expectancy: * At least 12 weeks Hematopoietic: * Granulocyte count at least 2,000/mm\^3 * Platelet count at least 150,000/mm\^3 Hepatic: * Not specified Renal: * Creatinine no greater than upper limit of normal Cardiovascular: * No clinically relevant atrial or ventricular arrhythmias * No myocardial infarction (MI) within the past 6 months (pretreatment ECG as only evidence of MI allowed) * No history of second- or third-degree heart blocks unless pacemaker implanted * History of first-degree heart block allowed Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No complete bowel obstruction * No prior allergic reaction to drugs containing Cremophor EL or compounds chemically related to study drugs * No condition that would preclude high-volume saline diuresis * No significant neurologic or psychiatric disorder that would preclude study compliance * No active uncontrolled infection * No neuropathy greater than grade 1 * No pre-existing hearing loss greater than grade 1 * No other concurrent serious illness or medical condition that would preclude study participation * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biological response modifiers or immunotherapy * No concurrent prophylactic colony-stimulating factors (CSFs) * Concurrent therapeutic CSFs allowed Chemotherapy: * No prior chemotherapy for ovarian cancer * No other concurrent cytotoxic agents Endocrine therapy: * No concurrent anticancer hormonal therapy Radiotherapy: * No prior radiotherapy for ovarian cancer Surgery: * No more than 6 weeks since prior planned pre-chemotherapy surgery for ovarian cancer * Planned interval debulking allowed * Concurrent second-look surgery allowed Other: * No prior non-surgical therapy for ovarian cancer * No other concurrent investigational drug therapy * No other concurrent anticancer treatment * Concurrent enrollment on CAN-NCIC-OV13/EORTC 55971 allowed
References
Publications (1)
- RESULTHoskins PJ, Vergote I, Stuart G, et al.: A phase III trial of cisplatin plus topotecan followed by paclitaxel plus carboplatin versus standard carboplatin plus paclitaxel as first-line chemotherapy in women with newly diagnosed advanced epithelial ovarian cancer (EOC) (OV.16). A Gynecologic Cancer Intergroup Study of the NCIC CTG, EORTC GCG, and GEICO. [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA5505, 2008.