Study of Paclitaxel in Patients With Ovarian Cancer
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| ClinicalTrials.gov Identifier: NCT00989131 |
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Recruitment Status :
Completed
First Posted : October 2, 2009
Last Update Posted : February 4, 2014
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Epithelial Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer | Drug: Paclical® Drug: Taxol® | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 789 participants |
| 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) |
| Study Start Date : | February 2009 |
| Actual Primary Completion Date : | October 2013 |
| Actual Study Completion Date : | October 2013 |
| Arm | Intervention/treatment |
|---|---|
| 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. |
- Progression free survival (PFS).
- Change in Area under the curve of CA 125
- Incidence and severity of hypersensitivity reactions
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
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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)
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
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| Principal Investigator: | Ignace Vergote, Prof. | Division of Gynaecological Oncology, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Belgium |
| Responsible Party: | Oasmia Pharmaceutical AB |
| ClinicalTrials.gov Identifier: | NCT00989131 |
| Other Study ID Numbers: |
OAS-07OVA |
| First Posted: | October 2, 2009 Key Record Dates |
| Last Update Posted: | February 4, 2014 |
| Last Verified: | February 2014 |
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Ovarian Cancer |
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Fallopian Tube Diseases |