Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Antibodies

Doxorubicin

Liposomal doxorubicin

Angiogenesis Inhibitors

Immunoglobulins

Taxane

Volociximab

Antibodies, Monoclonal

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Growth Inhibitors

Immunologic Factors

Three subjects will be treated with liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab, 7.5 mg/kg qwk

liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk

liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg q2wk (or other dose and schedule)

liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk (or other dose and schedule)

7.5 mg/kg, IV infusion every week until disease progression

M200 (Volociximab)

40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12.

Liposomal Doxorubicin

15 mg/kg, IV infusions every week until disease progression

15 mg/kg, IV infustions every other week until disease progression

Mihail Obrocea, MD

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. In all studies in solid tumors, volociximab has shown a favorable safety profile when administered at 10 mg/kg q2wks and more recently at 15 mg/kg qwk. A study of volociximab in combination with liposomal doxorubicin in subjects with ovarian cancer or primary peritoneal cancer who have relapsed after prior platin/taxane therapies is warranted to further evaluate the drug's efficacy and safety. The investigators have thus far activated stage 2 of this study at 11/25 sites. Worldwide, the study aims to enroll 150 subjects.

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.

Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)

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

Biogen

AbbVie (prior sponsor, Abbott)

Digestive System Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Pancreatic Cancer

Gastrointestinal Agents

Gemcitabine

Pancrelipase

Pancreatin

Antimetabolites

Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine

Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine

Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.

Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment

This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.

A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer

Phase 2 Open-Label Study of Volociximab (M200) in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer Not Previously Treated With Chemotherapy

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

volociximab

erlotinib hydrochloride

Robert A. Figlin, MD, FACP

RATIONALE: Monoclonal antibodies, such as volociximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Volociximab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving volociximab together with erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving volociximab together with erlotinib works in treating patients with stage III or stage IV non-small cell lung cancer.

OBJECTIVES:

Primary

* Evaluate the response rate in patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer treated with volociximab and erlotinib hydrochloride.

Secondary

* Evaluate the time to disease progression and duration of response in patients treated with this regimen.
* Evaluate the safety of this drug regimen in these patients.
* Evaluate the pharmacokinetics this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive volociximab IV over 30 minutes once every 2 weeks and oral erlotinib hydrochloride daily for 52 weeks in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed at 3 and 6 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Volociximab and Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Phase II Open-Label Study of Volociximab (M200) in Combination With Erlotinib (Tarceva™) in Previously Treated Patients With Locally Advanced (Stage IIIb) or Metastatic (Stage IV) Non-Small Cell Lung Cancer

National Cancer Institute (NCI)

Jonsson Comprehensive Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)	NCT00635193	Ovarian Cancer,...	M200 (Volocixim... Liposomal Doxor... M200 (Volocixim... M200 (Volocixim...	18 Years -	AbbVie
A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer	NCT00401570	Pancreatic Canc...	Volociximab Gemcitabine	18 Years -	AbbVie
Volociximab and Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer	NCT00278187	Lung Cancer	volociximab erlotinib hydro...	18 Years -	National Cancer Institute (NCI)
Volociximab and Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer	NCT00278187	Lung Cancer	volociximab erlotinib hydro...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for volociximab

Every month we try and update this database with for volociximab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for volociximab

Every month we try and update this database with for volociximab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for volociximab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.