Study of Paclitaxel in Patients With Ovarian Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Oasmia Pharmaceutical AB.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Oasmia Pharmaceutical AB
Collaborator:
Orion Corporation, Orion Pharma
Information provided by:
Oasmia Pharmaceutical AB
ClinicalTrials.gov Identifier:
NCT00989131
First received: September 28, 2009
Last updated: January 14, 2011
Last verified: January 2011
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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). [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
- T½ of CA 125 [ Designated as safety issue: No ]
- Safety and tolerability [ Designated as safety issue: Yes ]
- Response rate using CA 125 [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 650 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | March 2011 (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| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989131
Show 84 Study Locations
Contacts
| Contact: Margareta Eriksson, Clinical Trial Manager | +46 18 56 96 98 | margareta@oasmia.com |
Show 84 Study LocationsSponsors and Collaborators
Oasmia Pharmaceutical AB
Orion Corporation, Orion Pharma
Investigators
| Principal Investigator: | Ignace Vergote, Prof. | Division of Gynaecological Oncology, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Belgium |
More Information
No publications provided
| Responsible Party: | Clinical trial manager, Oasmia Pharmaceutical AB |
| ClinicalTrials.gov Identifier: | NCT00989131 History of Changes |
| Other Study ID Numbers: | OAS-07OVA |
| Study First Received: | September 28, 2009 |
| Last Updated: | January 14, 2011 |
| Health Authority: | Belarus: Ministry of Health Belgium: Federal Agency for Medicinal Products and Health Products Bulgaria: Bulgarian Drug Agency Croatia: Agency for Medicinal Product and Medical Devices Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency Hungary: National Institute of Pharmacy Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Serbia and Montenegro: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control Sweden: Medical Products Agency Ukraine: State Pharmacological Center - Ministry of Health |
Keywords provided by Oasmia Pharmaceutical AB:
|
Ovarian Cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube 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 Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms by Histologic Type Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013