A Phase 3 study of safety and efficacy of Karenitecin versus topotecan administered for 5 consecutive days every 3 weeks in patients with advanced epithelial ovarian cancer

Conditions: advanced epithelial ovarian cancer
MedDRA version: 14.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2006-006950-81-LT

Lead Sponsor: BioNumerik Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 500

Inclusion Criteria

1. Age = 18 years.
2. Documented histopathological or cytological diagnosis of stage III or IV epithelial ovarian cancer as defined by the International Federation of Gynecology and Obstetrics (FIGO) (Appendix D of the protocol).
3. The following tumor histological epithelial cell types will be accepted:
• Serous adenocarcinoma
• Endometrioid adenocarcinoma
• Mucinous adenocarcinoma
• Undifferentiated carcinoma
• Clear cell adenocarcinoma
• Mixed epithelial carcinoma
• Transitional cell carcinoma
• Adenocarcinoma (grade = 2) not otherwise specified.
4. Documented resistance to platinum/taxane-based chemotherapy, as indicated by relapse/progression while on or within 6 months of completion of treatment in a first-line or second-line setting; or a best response of SD after 6 cycles of platinum/taxane treatment in the first-line setting. Platinum/taxane-based regimens must have included either cisplatin or carboplatin, and paclitaxel or docetaxel.
5. Have measurable disease, defined by the presence of at least one radiographicallyconfirmed (computed tomography[CT]/magnetic resonance imaging [MRI]) measurable lesion that can be accurately measured in at least one dimension (longest diameter [LD] to be recorded) as = 20 mm with conventional techniques (CT/MRI), or = 10 mm with spiral CT scan.
6. Documentation of PD according to RECIST, WHO, or GCIG criteria; or progressive disease documented by increased CA-125 and confirmed by clinical symptoms, physical exam, or ultrasound following platinum/taxane treatment in the first-line or second-line setting, or a best response of SD after 6 cycles of platinum/taxane treatment in the first-line setting.
7. More than 3 weeks (21 days) must have elapsed since completion of the last treatment with any investigational or approved hormonal therapy, radiation, chemotherapy, or surgery, prior to randomization.
8. Have an ECOG PS = 2 within 14 days before randomization.
9. Have baseline laboratory parameters within the following ranges (without need for
hematopoietic growth factor use or transfusion support) within 14 days before randomization:
• Absolute neutrophil count (ANC) = 1.5 × 109/L
• Hemoglobin = 9 g/dL
• Platelet count = 100 × 109/L
• Total bilirubin = 1.5 times the upper limit of normal (ULN)
• Aspartate aminotransferase (AST/SGOT) = 2 × ULN
• Alanine aminotransferase (ALT/SGPT) = 2 × ULN
• Alkaline phosphatase = 2.5 × ULN.
10. Have a calculated creatinine clearance normalized to BSA that is > 40 mL/min determined within 14 days before randomization.
11. Disease-free period of > 5 years from any previous malignancies, excluding curativelytreated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
12. Provide informed consent prior to any screening procedures.

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

1. Patients with the following tumor histological epithelial cell types will not be accepted:
• Malignant Brenner or borderline tumor
• Low-potential (grade 0) tumor
• Squamous cell carcinoma
• Granulosa theca cell tumor
• Germ cell tumor
• Sex cord-stromal tumor
• Carcinosarcoma
• Mixed Müllerian tumor
• Metastatic carcinoma from other sites to ovary
• Low-grade (grade 1) adenocarcinoma.
2. Have current evidence of congestive heart failure (New York Heart Association Classification Class II or greater).
3. Have a recent onset (< 6 months prior to randomization) of angina pectoris, unstable angina pectoris, uncontrolled ventricular tachycardia, myocardial infarction, stroke, or transient ischemic attacks.
4. Have recent history (within 6 months) of uncontrolled seizures.
5. Have an active infection (including viral, fungal, bacterial, rickettsial, mycobacterial, or parasitic).
6. Have uncontrolled high blood pressure, uncontrolled diabetes mellitus, or other serious underlying medical condition not compatible with study entry.
7. Received prior treatment with a camptothecin (topotecan, CPT-11, or investigational camptothecins).
8. Received prior treatment with any platinum agent other than cisplatin or carboplatin.
9. Received prior radiation therapy to greater than one-third of the hematopoietic sites (one-third of the pelvis and axial skeleton combined).
10. Concurrently receiving investigational drug therapy for cancer treatment or investigational treatment for any other indication.
11. Have a positive pregnancy test or are unwilling to practice an effective contraceptive method during study (premenopausal patients).
12. Are breast feeding.
13. Have a life expectancy < 3 months.
14. Are judged by the Investigator to be unlikely to be able to fully comply with the study protocol and/or to complete the study or required study procedures.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to determine the safety and efficacy of intravenous karenitecin versus topotecan in patients with platinum/taxane-resistant advanced epithelial ovarian cancer.;Secondary Objective: None;Primary end point(s): The primary endpoint will be Progression Free Survival (PFS); defined as the time period from the date of randomization to the date of first radiographical documented progressive disease (PD) or date of death due to any cause, taking the event date that occurs first.<br>The date of PD will be determined by radiographical objective disease (RECIST) measurement.<br>

Secondary Outcome Measures

Name	Time	Method

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