Status:
TERMINATED
Weekly Carboplatin and Taxotere in Platinum Sensitive Relapsed Ovarian or Tubal or Primary Peritoneal Cancers
Lead Sponsor:
University of Saskatchewan
Collaborating Sponsors:
Sanofi
Conditions:
Platinum Sensitive Relapsed Ovarian Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
Weekly carboplatin and taxotere will be tolerable and effective as second line treatment of platinum-sensitive ( \>6 month treatment free interval) relapsed ovarian cancer Primary efficacy parameter ...
Detailed Description
Ovarian cancer is the sixth most common malignancy in women, with estimated 2500 cases diagnosed in 2001, and 1500 deaths. Despite maximal cytoreductive therapy, followed normally by a taxane and carb...
Eligibility Criteria
Inclusion
- Subjects must demonstrate their willingness to participate in the study (reliable and compliant for repeated treatments) and comply with its procedures by signing a written informed consent.
- Subjects must be 18 years of age or older.
- Subjects must have received a platinum regimen, with or without paclitaxel or cyclophosphamide, and have maintained a disease-free status for at least 6 months following the completion of first line therapy.
- Documented measurable or evaluable ovarian, tubal or primary peritoneal cancer by appropriate radiologic imaging (x-ray, or CT scan). Radiation therapy is allowed as long as not at the site of measurable disease. Recurrent disease based on elevated CA-125 alone is allowed, provided it meets the CA-125 progression definition.
- Subjects must have adequate hepatic, renal and marrow function (AST/ALT\< 3UNL, creatinine\<2UNL, ANC\>2, HGB\>90)
- Histologic diagnosis of ovarian, tubal or primary peritoneal cancer.
- Performance status: ECOG Score greater than or equal to 2.
- Subjects must have life expectancy of at least 6 months.
- Women of childbearing potential must have a negative pregnancy test at time of enrollment and must be using an acceptable method of birth- control during the study.
Exclusion
- Female subjects who are pregnant, breast-feeding, or unwilling to use adequate contraception.
- Any other active primary tumor under treatment, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix;
- Two or more prior chemotherapy regimens for ovarian cancer
- Serious infection within one month of commencement of treatment.
- Patients with known brain metastasis. However baseline CT of the head is not a must.
- Patients with severe gastro-intestinal symptoms- e.g.- partial obstruction, bleeding or diarrhea.
- Patients with Grade 2 or higher neuropathy \[NCI Common toxicity criteria\].
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00247988
Start Date
October 1 2003
End Date
April 1 2007
Last Update
April 24 2007
Active Locations (1)
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1
Saskatoon Cancer Center
Saskatoon, Saskatchewan, Canada, S7N 4H4