A Phase II Study of Weekly Docetaxel and Topotecan in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 46
• Participant gender: Female

Summary

Primary objective:

To estimate the overall clinical response rate (CR, PR, SD) of weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer.

Secondary objectives:

To access the safety and tolerability of this novel combination chemotherapy regimen of weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer

To estimate the progression free survival (PFS) and overall survival (OS) for women with recurrent platinum resistant ovarian or primary peritoneal cancer treated with this weekly docetaxel and weekly topotecan.

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

Details

• Lead Sponsor: Carilion Clinic
• Collaborator: GlaxoSmithKline
• Treatments: Docetaxel; Topotecan
• Last Updated: 2013-02-05

Criteria

Inclusion Criteria:

• All patients will have had histologically documented ovarian epithelial, fallopian tube or peritoneal cancer.

• Patients must have received one prior platinum- and paclitaxel based regimen

• Patients must be platinum-resistant defined as recurrence or progression of disease <6 months since previous treatment with a platinum based treatment regimen.

• Patients must not have received radiotherapy.

• Patients with the following histologic epithelial cell types are eligible:

• Serous Adenocarcinoma

• Endometrioid Adenocarcinoma

• Mucinous Adenocarcinoma

• Undifferentiated carcinoma

• Clear cell Adenocarcinoma

• Mixed epithelial carcinoma

• Transitional cell

• Malignant Brenner's tumor

• Adenocarcinoma NOS

• Patients may have measurable or evaluable disease whereas evaluable disease is defined as new onset pleural effusion, ascites or a rise in CA-125 level >2x institutions upper limit of normal x 2 now sooner than one week apart.

• Patients could not have more than two previous chemotherapeutic regimens for their advanced ovarian cancer.

• Patients must be at least 18 years of age

• Patients must have a serum creatinine < 1.5 mg/dl

• Patients must have adequate hematologic reserve (ANC > 1500/mm3, hemoglobin ≥ 9.0 gm/dL and platelets > 100,000/mm3)

• Patients must have adequate hepatocellular function:

• Total Bilirubin < institutional upper limits of normal (ULN), AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility

• Patients must have GOG performance status of 0, 1 or 2.

• Patients must a have signed, approved informed consent form on file.

Exclusion Criteria:

• Patients with borderline ovarian cancer.

• Patients with GOG performance status 3 or 4.

• Patients who have received prior topotecan and/or docetaxel.

• Patients who have a history of psychiatric illness or other concurrent severe and/or uncontrolled co-morbid medical condition that would preclude study completion (i.e., uncontrolled infection, hypertension, ischemic heart disease, myocardial infarction within 6 months, congestive heart failure).

• Patients with other invasive malignancies, with the exception of non-melanoma skin cancer or any evidence of the other cancer(s) present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.

• Patients with a history of severe acute hypersensitivity reaction to medications formulated with polysorbate 80.

• Patients with baseline peripheral neuropathy ≥ Grade 2.

• No use of investigational drugs or alternative medicine anticancer therapy within the last 4 weeks of 1st dose of study drug.

• Pregnant or lactating women with reproductive potential. (All patients enrolled in this study will be postmenopausal or have undergone surgery that includes hysterectomy and oophorectomy that would render them unable to conceive children.)