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Study of Paclitaxel in Patients With Ovarian Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00989131
First Posted: October 2, 2009
Last Update Posted: February 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oasmia Pharmaceutical AB
  Purpose

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®.


Condition Intervention Phase
Epithelial Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer Drug: Paclical® Drug: Taxol® Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Randomized, Multicenter Study in Patients With Recurrent Epithelian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficay and Safety of Paclitaxel (Micellar) Nanoparticles and Paclitaxel (Cremophor® EL)

Resource links provided by NLM:


Further study details as provided by Oasmia Pharmaceutical AB:

Primary Outcome Measures:
  • Progression free survival (PFS).
  • Change in Area under the curve of CA 125
  • Incidence and severity of hypersensitivity reactions

Secondary Outcome Measures:
  • Nadir and time to nadir of CA 125 during and after treatment
  • T½ of CA 125
  • Safety and tolerability
  • Response rate using CA 125
  • Overall survival

Enrollment: 789
Study Start Date: February 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel, micellar (Paclical®) Drug: Paclical®

250 mg/m2 of Paclical® is given as a one-hour IV infusion, followed by carboplatin, on day 1 of each 21 day cycle.

Number of Cycles: 6. Cycle 2-6 will be given with 3 weeks interval between treatments.

Active Comparator: Paclitaxel, CrEL (Taxol®) Drug: Taxol®

175 mg/m2 of Taxol® is given as 3 hour IV infusion, followed by carboplatin on day 1 of each 21 day cycle.

Number of Cycles: 6. Cycle 2-6 will be given with 3 weeks interval between treatments.


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989131


  Show 84 Study Locations
Sponsors and Collaborators
Oasmia Pharmaceutical AB
Investigators
Principal Investigator: Ignace Vergote, Prof. Division of Gynaecological Oncology, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Belgium
  More Information

Responsible Party: Oasmia Pharmaceutical AB
ClinicalTrials.gov Identifier: NCT00989131     History of Changes
Other Study ID Numbers: OAS-07OVA
First Submitted: September 28, 2009
First Posted: October 2, 2009
Last Update Posted: February 4, 2014
Last Verified: February 2014

Keywords provided by Oasmia Pharmaceutical AB:
Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action