Carboplatin and Paclitaxel (Taxol) versus Carboplatin and Paclitaxel (Taxol) followed by Carboplatin for frontline chemotherapy in advanced ovarian carcinoma. A Hellenic Cooperative Oncology Group Study
Carboplatin and Paclitaxel (Taxol) (8 cycles) versus Carboplatin and Paclitaxel (Taxol) (4 cycles) followed by Carboplatin (4 cycles) for frontline chemotherapy in advanced ovarian carcinoma. A randomised phase III study of overall survival by the Hellenic Cooperative Oncology Group
Hellenic Cooperative Oncology Group
412 participants
Apr 4, 2005
Interventional
Conditions
Summary
This is a randomized trial comparing carboplatin and paclitaxel (8 cycles) versus carboplatin and paclitaxel (4 cycles) followed by carboplatin (4 cycles) for frontline chemotherapy in advanced ovarian carcinoma. The main objective is to evaluate overall survival and. secondary endpoints are to evaluate disease-free survival, best response rate and to compare toxicity (especially neuroroxicity), between the two treatment arms.
Eligibility
Inclusion Criteria15
- Histologically confirmed epithelial carcinoma of ovarian origin, Federation of International Gynaecological Oncologists (FIGO) stage IIc, III or IV at laparotomy, regardless of measurable or non-measurable disease.
- Patients with non measurable or evaluable disease with either elevated or normal cancer antigen 125 (CA-125) levels according to the baseline assessment are eligible for the study but they are not evaluable for clinical response to chemotherapy.
- No previous chemotherapy or immunotherapy for this disease.
- There is no maximum age restriction, provided that patients are biologically fit.
- Laboratory values within the 2 weeks preceeding the start of the study treatment:
- White Blood Cell count (WBC) >3.5x10 ^9/l
- neutrophil count >1.5x10^9/liter (l)
- platelet count >100x10^9/l
- serum billirubin >1.5 miligrams (mg)/deciliter (dL)
- creatinine cleareance >50 milliliters (ml)/minute (min)
- Performance status World Health Organization(WHO) <=2.
- No symptoms or signs of cardiac insufficiency or acute coronary disease.
- Informed consent in accordance with the dispositions of the Helsinki, Tokyo and Venice declarations . The informed consent is to be registered in the patients’ records.
- Patients must be geographically accessible for treatment and follow-up.
- Patients must be enrolled within six weeks after the definitive laparotomy.
Exclusion Criteria8
- Prior chemotherapy or radiation treatment
- Other malignant tumor or tumor history, except for non melanoma skin cancer or radicaly excised in situ carcinoma of the uterine cervix
- Performance status (WHO)>2
- Absolute Neutrophil Count < 1.5x10^9/l or platelet count < 100x10^9/l.
- History of atrial or ventricular arrhythmias and/or history of congestive heart failure, even if medically controlled. History of clinically and electrocardiographically documented myocardial infarction within the last 6 months.
- Active infection or other serious underlying medical conditions which would impair the ability of the patient to receive protocol treatment, including prior allergic reactions to drugs containing chemophor, such as teniposide or cyclosporin.
- Administration of other therapeutic drugs or hormonal therapy during the study period.
- Patients with complete bowel obstruction and/or with brain metastases.
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Interventions
PACLITAXEL (TAXOL): 175mg/m2 intravenous (i.v.) over 3 hours (h) only on day 1 of each cycle, cycles 1 to 4 CARBOPLATIN: Area under the curve (AUC)6 i.v. over 1h only on day 1 of each cycle, cycles 1 to 4 Followed by CARBOPLATIN: 6 AUC i.v. over 1h only on day 1 of each cycle, cycles 5 to 8 Duration of therapy: 1 day per cycle. Cycles are repeated every 21 days.
Locations(1)
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ACTRN12610000309088