A Phase 2 Study of LY573636 as Treatment for Patients with Platinum-Resistant Ovarian Cancer Protocol H8K-MC-JZAG - ND

Conditions: patients with epithelial ovarian cancer who have received no more than 2 prior systemic treatment regimens for platinum-resistant disease.
MedDRA version: 6.1Level: PTClassification code 10061328

Registration Number: EUCTR2006-005971-17-IT

Lead Sponsor: ELI LILLY

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 50

Inclusion Criteria

[1] Patients must have a diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer that is not amenable to curative therapy. [2] Patients must have platinum-refractory or platinum-resistant disease: Platinum-refractory: failure to achieve at least a partial response to first-line platinum-based therapy (Markman and Bookman 2000). Platinum-resistant: progression in <6 months after a response to firstline platinum-based therapy (Markman and Bookman 2000). Patients who fail to respond (PR or CR) or progress <6 months after retreatment with platinum-based therapy will also be categorized as platinum-resistant. [3] Patients must have received at least 1, but no more than 2, prior platinum-based chemotherapeutic regimens (containing carboplatin, cisplatin, or another organoplatinum compound). At least 1 of the prior platinum regimens must have contained a taxane. [4] Patients must have: ? measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (Therasse et al. 2000) (refer to Protocol Attachment JZAG.6). or ? CA-125 >= 2X upper limit of normal (Rustin 2003), if they have otherwise nonmeasurable disease as defined by the RECIST guidelines (these patients are referred to as ?isolated CA-125 recurrence,? for purposes of this study). [5] For patients with prior radiation therapy: treatment to less than 25% of marrow-bearing area, completed at least 2 weeks prior to study enrollment. Patients must have recovered from the acute toxic effects of the treatment. [6] Are at least 18 years of age. [7] Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale (see Attachment JZAG.3). [8] Patients must have an estimated life expectancy of >=3 months. [9] Must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, hormone therapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia). [10] Have adequate organ function including: ? Bone Marrow Reserve: Absolute neutrophil count (ANC) >=1.5 x 109/L prior to treatment, platelets >=100 x 109/L, and hemoglobin >=8 g/dL (transfusions are not allowed to reach 8 g/dL prior to enrollment). ? Hepatic: Bilirubin <=1.5 times the upper limit of normal (ULN). Alkaline phosphatase and transaminases (ALT and AST) <=5 times ULN. ? Renal: Serum creatinine at or below the ULN. No known active renal disease. [11] Have a serum albumin level >=30 g/L or 3.0 g/dL. [12] Patients with reproductive potential should use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug. [13] Exhibit patient compliance and geographic proximity that allow for adequate follow-up. [14] Have given written informed consent approved by Lilly and the ethical review board (ERB)/institutional review board (IRB) governing the site.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[15] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. [16] Have received more than 2 lines of systemic therapy for platinumrefractory/ resistant disease. Neoadjuvant therapy is not counted as a previous systemic regimen for purposes of determining eligibility for this study. [17] Require regular, periodic paracentesis. [18] Patients with documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry. Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis. [19] Patients with serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator). [20] Patients with a second primary malignancy that could affect interpretation of the results. NOTE: Patients with adequately treated carcinoma of the skin (excluding melanoma) and patients with a prior history of malignancy who have been disease-free for more than 2 years are eligible. [21] Patients with serious preexisting medical conditions (at the investigator?s discretion). [22] Patients with electrocardiogram (ECG) abnormalities including QTC >470 msec. [23] Patients actively receiving warfarin (Coumadin) therapy for treatment of venous thrombosis or other prothrombotic conditions. NOTE: Patients receiving low dose (1 mg daily) warfarin will be allowed in this study. For those patients, more frequent monitoring of PT (INR)/aPTT will be required. [24] Persons who have previously completed or withdrawn from this study or any other study investigating LY573636. [25] Women who are pregnant or lactating.