Weekly Carboplatin and Taxotere in Platinum Sensitive Relapsed Ovarian or Tubal or Primary Peritoneal Cancers

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

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 will be response rate (CR and PR) according to RECIST criteria.

Secondary endpoints will be duration of response, progression free survival and overall survival. Toxicity will also be evaluated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Saskatchewan
• Collaborator: Sanofi
• Treatments: Carboplatin; Docetaxel

Criteria

Inclusion Criteria:

1. 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.

2. Subjects must be 18 years of age or older.

3. 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.

4. 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.

5. Subjects must have adequate hepatic, renal and marrow function (AST/ALT< 3UNL, creatinine<2UNL, ANC>2, HGB>90)

6. Histologic diagnosis of ovarian, tubal or primary peritoneal cancer.

7. Performance status: ECOG Score greater than or equal to 2.

8. Subjects must have life expectancy of at least 6 months.

9. 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 Criteria:

1. Female subjects who are pregnant, breast-feeding, or unwilling to use adequate contraception.

2. Any other active primary tumor under treatment, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix;

3. Two or more prior chemotherapy regimens for ovarian cancer

4. Serious infection within one month of commencement of treatment.

5. Patients with known brain metastasis. However baseline CT of the head is not a must.

6. Patients with severe gastro-intestinal symptoms- e.g.- partial obstruction, bleeding or diarrhea.

7. Patients with Grade 2 or higher neuropathy [NCI Common toxicity criteria].