Condition category
Cancer
Date applied
12/07/2005
Date assigned
23/08/2005
Last edited
02/07/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ago-ovar.de

Contact information

Type

Scientific

Primary contact

Mrs Gabriele Elser

ORCID ID

Contact details

Ludwig-Erhard-Str. 100
Wiesbaden
65199
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AGO-OVAR 15

Study information

Scientific title

Acronym

AGO-OVAR 15

Study hypothesis

Standard chemotherapy for ovarian cancer patients after primary cytoreductive surgery is paclitaxel in combination with carboplatin. Several phase III studies are evaluating the efficacy of a third drug within this standard trial either as a combined or as a consolidation therapy. The final results of these studies have not yet been published. The addition of farnesyltransferase (FT) inhibitors or epidermal growth factor inhibitors to primary chemotherapy are very promising approaches to optimize primary therapy. Lonafarnib is a FT inhibitor 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 mice models. Based upon positive results from clinical studies demonstrating enhanced activity when combining taxanes with lonafarnib, combination therapy of paclitaxel and carboplatin with lonafarnib is expected to have greater efficacy than standard therapy or FTI therapy alone in primary ovarian cancer patients.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Epithelial Ovarian Cancer, First-Line Treatment

Intervention

Paclitaxel/Carboplatin +/- Lonafarnib

The previous sponsor for this trial (until November 2009) was:
MedServ. GmbH (Germany)
Ludwig-Erhard-Str. 100,
65199 Wiesbaden
Germany

Intervention type

Drug

Phase

Phase II

Drug names

Paclitaxel/Carboplatin and Lonafarnib

Primary outcome measures

Comparison of the effect (progression-free survival [PFS]) of paclitaxel/carboplatin and lonafarnib to that of paclitaxel/carboplatin in patients with previously untreated epithelial cancer of the ovary FIGO stages IIB–IV. The primary purpose of this study is to determine whether the additional effect of lonafarnib is sufficient to conduct a phase III study.

Secondary outcome measures

The secondary objectives are to evaluate response to treatment and overall survival, and to assess the safety in both treatment arms and to assess exposure (PK) and PD of lonafarnib.

Overall trial start date

01/09/2005

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Previously untreated patients with a histologically confirmed diagnosis of cancer of the ovary or the fallopian tube or extra-ovarian papillary serous tumors
FIGO stage IIB–IV regardless of measurable or non-measurable disease
2. Age ≥18 years
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2
4. Life-expectancy of at least 6 months
5. Adequate bone marrow, renal and hepatic function defined as
white blood cell count (WBC) >3.0/nl, Neutrophils (ANC) ≥1.5/nl, Platelets ≥100/nl, Hemoglobin >6 mmol/l (>10.0 g/dl), Bilirubin ≤1 x upper limit of normal range
6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <1.5 x upper limit of normal range
7. Alkaline phosphatase <2.5 x upper limit of normal range
8. Estimated glomerular filtration rate GFR ≥50 ml/min according to Jelliffe or Cockroft-Gault formula
9. 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
10. Patients must be geographically accessible for treatment and follow-up
11. Time between definitive surgery and randomization ≥6 weeks

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Ovarian tumors of low malignant potential (borderline tumors
2. Non-epithelial ovarian or mixed epithelial/non epithelial tumors (e.g. mixed Mullerian tumors)
3. Patients who have received previous chemotherapy or radiotherapy
4. Prior treatment with FT inhibitors
5. 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)
6. Complete bowel obstruction or the presence of symptomatic brain metastases
7. 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
8. Patients with a history of seizure disorder or central nervous system disorders
9. Pre-existing motor or sensory neurologic pathology or symptoms >National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grade 1
10. History of congestive heart failure (New York Heart Association [NYHA] Classification >2), even if medically controlled
11. History of clinical and electrocardiographically documented myocardial infarction within the last 6 months
12. History of atrial or ventricular arrhythmias (≥LOWN II)
13. Patients with significant Fridericia QTc (QTcF) prolongation at Baseline (i.e. QTcF >470 msec)
14. Patients with severe active infection
15. 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
16. Fertile women not using adequate contraceptive methods
17. Women who are pregnant or breast feeding
18. 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)
19. Patients who have used any investigational drugs within 30 days of study entry
20. Patients who are participating in any other clinical study
21. Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent

Recruitment start date

01/09/2005

Recruitment end date

30/09/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Ludwig-Erhard-Str. 100
Wiesbaden
65199
Germany

Sponsor information

Organisation

AGO Research GmbH (Germany)

Sponsor details

Kaiser-Friedrich-Ring 71
Wiesbaden
65185
Germany

Sponsor type

Industry

Website

http://www.ago-ovar.de

Funders

Funder type

Charity

Funder name

AGO Ovarian Cancer Study Group (AGO-OVAR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results http://www.ncbi.nlm.nih.gov/pubmed/22564713

Publication citations

  1. Results

    Meier W, du Bois A, Rau J, Gropp-Meier M, Baumann K, Huober J, Wollschlaeger K, Kreienberg R, Canzler U, Schmalfeldt B, Wimberger P, Richter B, Schröder W, Belau A, Stähle A, Burges A, Sehouli J, Randomized phase II trial of carboplatin and paclitaxel with or without lonafarnib in first-line treatment of epithelial ovarian cancer stage IIB-IV., Gynecol. Oncol., 2012, 126, 2, 236-240, doi: 10.1016/j.ygyno.2012.04.050.

Additional files

Editorial Notes