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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cancer

Thank you

Trial Information

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


This is an open-label study of liposomal doxorubicin with or without volociximab for the
treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer
relapsed after prior therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic
integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with
a surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy
in terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft
models. In clinical studies, volociximab has been evaluated in several solid tumor types,
including pancreatic, renal, and melanoma, with many subjects who entered the studies with
progressive disease remaining progression-free for several months.


Inclusion Criteria:



- 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).

- Recurrent or persistent disease.

- Received no more than 2 prior cancer treatment regimens, at least one of which must
have included a platinum/taxane based therapy. If the same regimen is given more than
once, it will count as one regimen. If components of a regimen are given more than
once using the same schedule, it will count as one regimen.

- At least 1 target lesion to assess response by RECIST criteria. (Tumors within a
previously irradiated field are designated as non-target)

- Other protocol-defined inclusion criteria apply.

Exclusion Criteria:

- Subjects taking immunomodulatory agents including, but not limited to, interferons,
interleukins, systemic steroids, cyclosporine, tacrolimus, calcineurin inhibitors,
chronic low dose methotrexate, or azathioprine. (Use of inhaled or intranasal
steroids or oral steroids 10 mg/day prednisone or its equivalent are permitted.)

- Subjects who require treatment with an anti coagulant with the exception of low dose
AspirinĀ® (81 mg/day), warfarin (1 mg/day), or heparin for IV catheter patency

- Evidence of bleeding diathesis or coagulopathy. (Prior history of DVT will not
exclude subjects from participating in this study.)

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 1.

- Non-healing wound, ulcer, or bone fracture.

- 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.

- Active infection requiring systemic antibiotics, antivirals, or antifungals including
HIV/AIDS, hepatitis B, or hepatitis C infection.

- Other protocol-defined exclusion criteria apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. To evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin.

Outcome Time Frame:

50-57 days

Safety Issue:

Yes

Principal Investigator

Mihail Obrocea, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

206OC202

NCT ID:

NCT00635193

Start Date:

July 2007

Completion Date:

October 2009

Related Keywords:

  • Ovarian Cancer, Primary Peritoneal Cancer
  • Ovarian neoplasms
  • Angiogenesis inhibitors
  • Angiogenesis
  • Volociximab
  • Ovarian cancer
  • Antibody
  • Monoclonals
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

Site Reference ID/Investigator# 75281Anaheim, California  92801
Site Reference ID/Investigator# 75275Redondo Beach, California  90277
Site Reference ID/Investigator# 75296Sunrise, Florida  33323
Site Reference ID/Investigator# 75299Atlanta, Georgia  30309
Site Reference ID/Investigator# 75300Savannah, Georgia  31404
Site Reference ID/Investigator# 75301Hinsdale, Illinois  60521
Site Reference ID/Investigator# 75274Baltimore, Maryland  21215
Site Reference ID/Investigator# 75294Jackson City, Missouri  65109
Site Reference ID/Investigator# 75279Oklahoma City, Oklahoma  73104
Site Reference ID/Investigator# 75295Corpus Christi, Texas  78404
Site Reference ID/Investigator# 75280Dallas, Texas  75246
Site Reference ID/Investigator# 75297Danville, Virginia  23185
Site Reference ID/Investigator# 75298Williamsburg, Virginia  23185
Site Reference ID/Investigator# 75278Green Bay, Wisconsin  54301