A prospective, multicentre, randomised trial of carboplatin flat dosing vs. intrapatient dose escalation in first line chemotherapy of ovarian, fallopian tube and primary peritoneal cancers

Not Applicable

Completed

• Conditions: Advanced ovarian cancer; Cancer; Malignant neoplasm of other and unspecified female genital organs

• Registration Number: ISRCTN47645935
• Lead Sponsor: niversity of Glasgow (UK)

Brief Summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23041585

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-04-21
• Study Completion: 2005-05-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1300

Inclusion Criteria

Current information as of 11/08/09:
1. Patients with histologically confirmed epithelial ovarian carcinoma, or primary fallopian tube carcinoma, considered unsuitable or unwilling for treatment with platinum-taxane combination therapy. Patients with peritoneal carcinomatosis (ovarian-type) are also eligible, without necessarily having histological proof of a primary source in the ovary, provided that the tumour is not mucin-secreting (see exclusion criteria).
2. Female, aged 18 or over.
3. FIGO stages Ic-IV with or without successful cytoreductive surgery at staging laparotomy. Stage Ic patients will be limited to those with malignant cells in ascitic fluid/peritoneal washings, tumour on the surface of the ovary, or pre-operative capsule rupture.
4. Written informed consent
5. Can comply with follow up requirements
6. Intention to treat patient within 8 weeks of initial surgery.

Initial information at time of registration:
Patients with histologically confirmed epithelial ovarian carcinoma (stage IC - IV), or primary fallopian tube carcinoma, considered unsuitable or unwilling for treatment with platinum-taxane combination therapy

Exclusion Criteria

Added 11/08/09:
1. ECOG performance > 3
2. Prior treatment with chemotherapy and radiotherapy
3. Inadequate bone marrow function defined as neutrophils < 1.5 or plateles < 100
4. Inadequate renal function as defined by calculated creatinine clearance (Cockcroft-Gault) of < 30ml/min. Obstructive hydronephrosis as a cause of borderline (eg 30-45 ml/min) renal function should be investigated and treated prior to study entry.
5. Inadequate liver function as defined by bilirubin > upper limit of normal or AST/ALT >2.5 x upper limit of normal or ALP > 5 x upper limit of normal.
6. Concurrent severe and/or uncontrolled co-morbid medical condition (i.e. uncontrolled infection, hypertension, ischaemic heart disease, myocardial infarction within previous 6 months, congestive heart failure)
7. Patient with mixed mesodermal tumours
8. Patients with boderline ovarian tumours or tumours termed possibly malignant
9. Adenocarcinoma of unknown origin, if histologically shown

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Added 11/08/09:<br>Progression-free survival

Secondary Outcome Measures

Name	Time	Method
Added 11/08/09:<br>1. Toxicity<br>2. Quality of life<br>3. Response rates (clinical and CA125)<br>4. Overall survival