Study of Paclitaxel in Patients With Ovarian Cancer

Oasmia Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Primary Peritoneal Cancer

Epithelial Ovarian Cancer

Fallopian Tube Cancer

Treatments

Drug: Paclical®

Drug: Taxol®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00989131

OAS-07OVA

Details and patient eligibility

About

RATIONALE: Paclitaxel is one of the most widely used human anticancer agents. Paclitaxel has a low degree of solubility and Cremophor EL is typically used as the solubiliser. Cremophor EL is known to cause hypersensitivity reactions that can be life-threatening. As Paclical® does not contain Cremophor EL, hypersensitivity reactions can be expected to be less.

PURPOSE: To study the efficay and safety of two different formulations of paclitaxel, Paclical® and Taxol®.

Enrollment

789 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
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.
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.
Age > 18 years
Eastern Cooperative Oncology Group (ECOG) performance score 0-2
Life expectancy >12 weeks
Patient has blood counts at baseline of:
- Absolute neutrophil count (ANC) >1,5 x 109 / L.
- Platelet count >100 x 109 / L
- Haemoglobin (Hb) ≥9g/dl (can be post transfusion)
Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) < 2 x UNL
Total bilirubin ≤1.5 x UNL.
Adequate renal function defined as serum creatinine < 2.0 mg/dl or 177μmol/l.
Alkaline phosphatase (ALP) < 2.5 x UNL
Signed informed consent obtained

Exclusion criteria

Patient has peripheral neuropathy of grade ≥ 2 per NCI-CTCAE version 3.0
Surgical procedure due to progressive disease within 4 weeks of any of the CA-125 measurements
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).
Bowel obstruction at screening
Tumours of other origin or histology
Patient of child-bearing potential, not practising adequate contraception, or pregnant or lactating women
Patient has a history of severe allergy or severe hypersensitivity to study drugs
Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs, e.g. heart, lung or kidney disease, suspicion of brain metastasis or mental disorder to make the patient unable to participate in the study
Participation in an investigational drug study within 4 weeks prior to study treatment (Day 1, Cycle 1)