Comparison of Paclitaxel/Carboplatin and Lonafarnib to Paclitaxel/Carboplatin for First-line Treatment of Ovarian Cancer

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare the effects of Paclitaxel/Carboplatin and Lonafarnib to those of Paclitaxel/Carboplatin in primary treatment of patients with epithelial ovarian cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AGO Study Group
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Lonafarnib; Paclitaxel

Criteria

Inclusion Criteria:

• Previously untreated patients with a histologically confirmed diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors FIGO stage IIB-IV, regardless of measurable or non-measurable disease

• Age >= 18 years

• ECOG performance status <= 2

• Life-expectancy of at least 6 months

• Adequate bone marrow, renal and hepatic function:

WBC >= 3.0 x 10^9/l; Neutrophils (ANC) >= 1.5 x 10^9/l; Platelets >= 100 x 10^9/l; Hemoglobin > 6 mmol/l (> 10.0 g/dl); Bilirubin <= 1 x upper limit of normal range; Alkaline phosphatase <= 2.5 x upper limit of normal range; estimated GFR >= 50 ml/min according to Jelliffe or Cockroft-Gault formula

• Patients who have given their signed and written informed consent to participate in the trial after fully understanding the implication and constraints of the protocol

• Patients must be geographically accessible for treatment and follow-up

• Time between definitive surgery and randomization into the study <= 6 weeks

Exclusion Criteria:

• Ovarian tumors of low malignant potential (borderline tumors)

• Non-epithelial ovarian or mixed epithelial/nonepithelial tumors (e.g. Mixed Mullerian tumors)

• Patients who have received previous chemotherapy or radiotherapy

• Prior treatment with FT inhibitors

• Patients with a prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)

• Complete bowel obstruction or the presence of symptomatic brain metastases

• Concurrent severe medical problems unrelated to malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy

• Patients with a history of seizure disorder or central nervous system disorders; pre-existing motor or sensory neurologic pathology or symptoms > NCI grade 1

• History of congestive heart failure (NYHA Classification > 2, even if medically controlled.

• History of clinical and electrocardiographically documented myocardial infarction within the last 6 months.

• History of atrial or ventricular arrhythmias (>= LOWN II)

• Patients with significant Fridericia QTc (QTcF) prolongation at Baseline (ie. QTcF >= 470 msec)

• Patients with severe active infection

• Patients with a history of severe hypersensitivity reactions to products containing Cremophor EL (cyclosporin or vitamin K) and/or patients with known hypersensitivity to compounds chemically related to Carboplatin and Paclitaxel

• Women with childbearing potential and who are sexually active and unwilling to use a medically acceptable method of contraception (oral contraceptive, diaphragm with spermicide, intrauterine device, condom with spermicide)

• Women who are pregnant or breast feeding

• Administration of other anticancer therapy or simultaneous chemotherapeutic and/or hormonal drugs, or radiotherapy during the study treatment period (except: hormonal replacement therapy and/or steroid antiemetics)

• Patients who are participating in any other clinical study

• Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent