Study of Paclitaxel in Patients with Ovarian Cancer

Phase 1

• Conditions: Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.; MedDRA version: 14.1Level: LLTClassification code 10052171Term: Peritoneal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-002668-32-DK
• Lead Sponsor: Oasmia Pharmaceutical AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-26
• Last Update Posted: 12 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 850

Inclusion Criteria

1.Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
2.Patients relapsing > 6 months after end of first line or second line treatment including platinum based therapy. Prior therapy and duration of response will be documented in the CRF for descriptive analysis.
3.CA 125 >2 x upper normal limit (UNL) documented at two occasions, with more than one week interval, according to appendix I, patient groups A and B, measurable/non-measurable disease.
4.Age > 18 years.
5.Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
6.Life expectancy >12 weeks.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patient has peripheral neuropathy of grade = 2 per NCI- CTCAE version 3.0.
2.Surgical procedure due to progressive disease within 4 weeks of any of the CA-125 measurements.
3.Patient receiving concurrent hormonal, immuno-, or radiotherapy. Treatment must have stopped for at least 4 weeks before start of drug treatment (Day 1 , Cycle 1).
4.Bowel obstruction at screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified