Study of Paclitaxel in Patients With Ovarian Cancer

Phase 3

Completed

• Conditions: Epithelial Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer
• Interventions: Drug: Paclical®; Drug: Taxol®

• Registration Number: NCT00989131
• Lead Sponsor: Oasmia Pharmaceutical AB

Brief Summary

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®.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-09-28
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-03
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 789

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paclitaxel, micellar (Paclical®)	Paclical®	-
Paclitaxel, CrEL (Taxol®)	Taxol®	-

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS).
Incidence and severity of hypersensitivity reactions
Change in Area under the curve of CA 125

Secondary Outcome Measures

Name	Time	Method
T½ of CA 125
Safety and tolerability
Overall survival
Nadir and time to nadir of CA 125 during and after treatment
Response rate using CA 125

Trial Locations

Locations (82)

Gomel Regional Clincial Oncology Center; 🇧🇾 Gomel, Belarus

Minsk City Clinical Oncology Hospital; 🇧🇾 Minsk, Belarus

Alexandrov National Cancer Center of Belarus; 🇧🇾 Minsk, Belarus

Vitebsk Regional Clinical Oncology Center; 🇧🇾 Vitebsk, Belarus

Department of gyneacology, Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

Regional Oncology Dispensary; 🇧🇬 Stara Zagora, Bulgaria

Hospital for a Active Treatment, Tsaritsa Yoanna; 🇧🇬 Sofia, Bulgaria

Klinički Bolnički Centar Rijeka; 🇭🇷 Rijeka, Croatia

Klinički Bolnički Centar Split; 🇭🇷 Split, Croatia

Klinikčki Bolnički Centar Zagreb; 🇭🇷 Zagreb, Croatia

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