A Phase 1/2, Open-Label, Adaptive, Randomized Study of Liposomal Doxorubicin With or Without M200 (Volociximab) for the Treatment of Subjects With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer That Have Relapsed After Prior Therapy With a Platinum/Taxane-Based Chemotherapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 150

Inclusion Criteria

1. Must give written informed consent and any authorizations required by local law
(e.g., Protected Health Information [PHI]).
2. Females aged =18 years old at the time of informed consent.
3. Advanced (Stage III or IV) histologically-documented epithelial ovarian cancer or primary peritoneal cancer (excluding small, round-cell histologies).
4. Recurrent or persistent disease.
5. Received no more than 2 prior cancer treatment regimens, at least one of which must have included a platinum/taxane-based therapy (carboplatinum, cisplatinum, or another organoplatinum compound). If the same regimen is given more than once, it will only count as one regimen. Similarly, if components of a regimen are given more than once using the same schedule, it will only count as one regimen.
6. At least 1 target lesion to assess response by RECIST criteria. (Tumors within a previously irradiated field are designated as non-target.)
7. ECOG Performance Status =1.
8. Life expectancy >12 weeks.
9. Available paraffin block or unstained paraffin sections on glass slides containing representative tumor tissue from the most recent tumor biopsy/resection.
10. Subjects of child-bearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment (about 5 half lives).
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. Clinical laboratory values outside of the following laboratory thresholds:
a) Granulocyte count <1500/µL
b) Platelet count <75,000/µL
c) Hemoglobin <8.5 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoeitin [Aranesp®] is permitted)
d) Serum bilirubin >2.0 × upper limits of normal (ULN)
e) AST and ALT >2.5 × ULN (AST and ALT >5 × ULN for subjects with liver
metastasis)
f) Serum creatinine >2.0 mg/dL
g) International normalized ratio (INR) >1.5
h) Activated partial thromboplastin time (aPTT) >1.5 × ULN
2. Unstable angina or a history of myocardial infarction within 6 months prior to Day 1.
3. New York Heart Association (NYHA) =Grade II congestive heart failure.
4. Subjects who have received prior (liposomal) anthracycline or anthracenedione therapy.
5. Any investigational, anti-cancer therapy within 6 weeks prior to Day 1.
6. Any non-investigational, anti-cancer therapy within 4 weeks prior to Day 1.
7. Prior treatment with anti-angiogenic agents.
8. Subjects who are taking concomitant immunomodulatory agents including, but not limited to, interferons, interleukins, systemic steroids, cyclosporine, tacrolimus, calcineurin inhibitors, chronic low-dose methotrexate, or azathioprine. (The use of inhaled or intranasal steroids or oral steroids at a dose of =10 mg/day prednisone
or its equivalent are permitted.)
9. Subjects who require treatment with an anti-coagulant with the exception of low-dose Aspirin® (=81 mg/day), warfarin (=1 mg/day), or heparin for IV catheter patency.
10. Subjects with a left ventricular ejection fraction (LVEF) <50%.
11. History of stroke or transient ischemic attack within 6 months prior to Day 1.
12. Clinically significant peripheral vascular disease.
13. Evidence of bleeding diathesis or coagulopathy. (Note: Prior history of deep vein thrombosis will not exclude subjects from participating in this study.)
14. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1.
15. Serious, non-healing wound, ulcer, or bone fracture.
16. Evidence of autoimmune disease including, but not limited to, ulcerative colitis, Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma,
and other disease in which immune function or immune competence is known to be
impaired.
17. Active infection requiring systemic antibiotics, antivirals, or antifungals including
HIV/AIDS, hepatitis B, or hepatitis C infection.
18. Any history of lymphoproliferative disorder.
19. Known human anti-murine antibody (HAMA) and/or human anti-chimeric antibody
(HACA).
20. Known central nervous system or brain metastases.
21. History of other malignancies within 3 years of Day 1, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal, or squamous cell skin cancer.
22. Pregnant (positive pregnancy test) or lactating.
23. Inability to comply with study and follow-up procedures.
24. Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that in the opinion of the Investigator gives reasonable suspicion
of a disease or condition that contraindicates the use of an investigational drug or
that may affect the interpretation of the results or render the subject at high risk from treatment complications.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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