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An Open-label, Multicenter, Randomized Phase II Study to Compare the Effects of Paclitaxel/Carboplatin and Lonafarnib to Those of Paclitaxel/Carboplatin for First-line Treatment of Patients With Epithelial Ovarian Cancer FIGO Stages IIB-IV


Phase 2
18 Years
N/A
Not Enrolling
Female
Epithelial Ovarian Cancer

Thank you

Trial Information

An Open-label, Multicenter, Randomized Phase II Study to Compare the Effects of Paclitaxel/Carboplatin and Lonafarnib to Those of Paclitaxel/Carboplatin for First-line Treatment of Patients With Epithelial Ovarian Cancer FIGO Stages IIB-IV


Today the standard therapy for patients with advanced ovarian carcinoma is paclitaxel and
carboplatin. Lonafarnib is a farnesyl transferase inhibitor (FTI) that is active against a
broad spectrum of tumor cell lines in vitro and tumor xenografts in nude mice. Lonafarnib
has single-agent antitumor activity as well as enhanced activity in combination with taxanes
in a number of tumor cell lines and in vivo models.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

every 3 months until PD

Safety Issue:

No

Principal Investigator

Werner Meier, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ev. Krankenhaus, Düsseldorf, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AGO-OVAR 15

NCT ID:

NCT00281515

Start Date:

January 2006

Completion Date:

December 2011

Related Keywords:

  • Epithelial Ovarian Cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

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