A Phase 2, Single-Arm Study of Volociximab Monotherapy in Subjects With Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer

NCT00516841 | Terminated Phase 2

• 1 other identifier: 206OC201
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 23

Brief Summary

To evaluate the efficacy of voloxicimab when administered at 15 mg/kg qwk in subjects with platinum-resistant, advanced epithelial ovarian cancer or primary peritoneal cancer.

Conditions

Ovarian Cancer; Peritoneal Neoplasms

Keywords

epithelial ovarian cancer; peritoneal cancer; platinum-resistant ovarian cancer; Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy as measured by objective response rate (ORR). Tumor response based on RECIST criteria.

  Baseline, and every 8 weeks on study

Study Arms (1)

volociximab

EXPERIMENTAL

15 mg/kg volociximab once weekly

Drug: Volociximab

Interventions

Volociximab DRUG

15 mg/kg weekly, IV infusions, for 8 weeks or until disease progression or unacceptable toxicity develops

Also known as: M200

volociximab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information \[PHI\]).
• Females aged ≥18 years old at the time of informed consent.
• Advanced (Stage III or IV), histologically-documented epithelial ovarian cancer or primary peritoneal cancer (excluding small, round-cell histologies).
• Radiologically-documented evidence of progressive disease.
• Platinum-resistant disease defined as having a best response of SD or disease progression during or within 6 months of discontinuing a platinum-based chemotherapy (carboplatinum, cisplatinum, or another organoplatinum compound).
• Progression during or following treatment with topotecan or liposomal doxorubicin.
• Three or fewer prior chemotherapy regimens (including a platinum-based therapy).
• At least 1 measurable target lesion in accordance with RECIST criteria to assess clinical response (tumors within a previously irradiated field are designated as non-target).
• ECOG Performance Status ≤1.
• Life expectancy \>12 weeks.
• Available paraffin block or unstained paraffin sections on glass slides containing representative tumor tissue from the most recent tumor biopsy/resection.
• 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).

You may not qualify if:

• Screening clinical laboratory values:
• Absolute neutrophil count \<1500/µL
• Platelet count \<75,000/µL
• Hemoglobin \<8.5 g/dL (hemoglobin may be supported by transfusion, erythropoietin, or other approved hematopoietic growth factors; darbopoeitin \[Aranesp®\] is permitted)
• Serum bilirubin \>2.0 x upper limit of normal (ULN)
• AST and ALT \>2.5 x ULN (AST and ALT \>5 × ULN for subjects with liver metastasis)
• Serum creatinine \>2.0 mg/dL
• International normalized ratio (INR) \>1.5
• Activated partial thromboplastin time (aPTT) \>1.5 × ULN
• Clinically significant peripheral vascular disease.
• Non-epithelial ovarian tumors.
• Active infection requiring systemic antibiotics, antivirals, or antifungals including HIV/AIDS, hepatitis B, or hepatitis C infection.
• History of abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to Day 1.
• Serious, non-healing wound, or bone fracture.
• Known central nervous system or brain metastases.

Sponsors & Collaborators

• Facet Biotech: lead
• Biogen: collaborator

Study Sites (23)

UCLA JCCC Clinical Research Unit

Los Angeles, California, 90024, United States

Location

UCI Medical Center

Orange, California, 92868-3201, United States

Location

Sharp Hospital

San Diego, California, 92123, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins Kimmel Cancer Center

Baltimore, Maryland, 21231-1000, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Billings Clinic (MCMRC network)

Billings, Montana, 59101, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Oklahoma University Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Texas Oncology PA, Presbyterian

Dallas, Texas, 75231, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

Tom Baker Cancer Center

Calgary, Alberta, T2N4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G1Z2, Canada

Location

London Health Sciences Center

London, Ontario, NGA4L6, Canada

Location

McGill University Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

volociximab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Carolyn Matthews, MD

  Mary Crowley Medical Research Center

  PRINCIPAL INVESTIGATOR

• Minal Barve, MD

  Texas Oncology PA, Presbyterian

  PRINCIPAL INVESTIGATOR

• James Burke, MD

  Billings Clinic (MCMRC network)

  PRINCIPAL INVESTIGATOR

• Dana Glenn, MD

  Sharp Hospital

  PRINCIPAL INVESTIGATOR

• Russell Schilder, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

• Nikki Spellman, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Michael Gold, MD

  Oklahoma University Health Science Center

  PRINCIPAL INVESTIGATOR

• Richard Penson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Mark Einstein, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

• Robert Holloway, MD

  Florida Hospital Cancer Institute

  PRINCIPAL INVESTIGATOR

• Deborah Armstrong, MD

  Johns Hopkins Kimmel Cancer Center

  PRINCIPAL INVESTIGATOR

• Snehel Bhoola, MD

  Memorial Health University Medical Center

  PRINCIPAL INVESTIGATOR

• Eric Winquist, MD

  London Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Ernst Lengyel, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• John Glaspy, MD

  UCLA JCCC Clinical Research Unit

  PRINCIPAL INVESTIGATOR

• Krish Tewari, MD

  UCI Medical Center

  PRINCIPAL INVESTIGATOR

• C. William Helm, MD

  James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

• John Glaspy, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Michael Sawyer, MD

  Cross Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2007
• First Posted: August 16, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

CA (4); US (19)