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Phase II, Open-Label, Study of CAELYX and Carboplatin Intermediate Platinum-Sensitive (6-12 Months Treatment-Free Interval) Relapsed Epithelial Ovarian Cancer.


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms

Thank you

Trial Information

Phase II, Open-Label, Study of CAELYX and Carboplatin Intermediate Platinum-Sensitive (6-12 Months Treatment-Free Interval) Relapsed Epithelial Ovarian Cancer.


Inclusion Criteria:



- Age >=18 years old

- Subject must have histological diagnosis of epithelial ovarian cancer

- Subject must have received a taxane and platinum regimen and have maintained a
treatment-free status for at least six months and not more than twelve months
following completion of first line therapy.

- Subject must have measurable ovarian cancer by appropriate radiological imaging.

- ECOG performance Score of 0 or 1.

- Subject's life expectancy must be > 6 months.

- Subject must have normal organ function, except if abnormal due to tumor involvement:

- Adequate bone marrow function (platelets >=100 X 10^9/L, hemoglobin >=100 g/L,
neutrophils >=1.5 X 10^9/L)

- Adequate renal function (serum creatinine<=1.5 X the upper limit of normal (ULN)

- Adequate liver function (bilirubin and AST or ALT<=2 times ULN, unless related
to primary disease.

- MUGA scan must indicate left ventricular ejection fraction above 90%.

- Women of childbearing potential must be using adequate contraception (prescribed
under medical supervision) and have a negative pregnancy test at the time of
enrollment.

- Subject must be able to sign written informed consent.

Exclusion Criteria:

- Subject who is pregnant or is breast feeding.

- Subject who has history of cardiac disease, with New York Heart Association Class II
or greater.

- Subject with a history of severe hypersensitivity reactions to products containing
Cremophor® EL.

- Subject with clinically significant hepatic disease.

- Subject who has uncontrolled bacterial, viral, or fungal infection.

- Subject who exhibits confusion or disorientation.

- Subject with any condition that would prevent adequate follow-up.

- Subject with a history of prior malignancy treated with systemic chemotherapy or
radiotherapy.

- Subject who has received two or more prior chemotherapy regimens for ovarian cancer.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate, according to RECIST criteria; Partial response rate, according to RECIST criteria

Outcome Time Frame:

Complete or partial response: re-evaluation 4 weeks later to confirm response; Upon completion of chemotherapy: follow-up every 2 months until documentation of progressive disease; All patients will be followed for a minimum of one year for survival

Safety Issue:

No

Authority:

Canada: Health Canada

Study ID:

P03625

NCT ID:

NCT00780039

Start Date:

October 2003

Completion Date:

September 2007

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms

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