A Phase 1b Study With Volociximab in Combination With Carboplatin and Paclitaxel in First-line, Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT00654758 | Completed Phase 1 DMC

• 2 other identifiers: M200-12112007-003396-39
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of this study is to examine the safety of volociximab in combination with a standard treatment of carboplatin and paclitaxel in subjects previously untreated with chemotherapy for advanced stage (IIIB/IV) non-small cell lung cancer (NSCLC).

Conditions

Non-small Cell Lung Cancer

Keywords

cancer; carcinoma; chemotherapy; monoclonal antibody therapy; anti-angiogenesis

Outcome Measures

Primary Outcomes (1)

• To determine the maximum tolerated dose (MTD) of volociximab given at different doses in combination with carboplatin and paclitaxel

  Dose escalation phase of the trial

Secondary Outcomes (2)

• Pharmacokinetics of volociximab

  Approximately 2.5 years

• Efficacy of volociximab in combination with carboplatin/paclitaxel

  Approximately 2.5 years

Study Arms (1)

1

EXPERIMENTAL

Escalating doses of volociximab at 10, 20, and 30 (or 15) mg/kg with carboplatin and paclitaxel.

Drug: M200 (Volociximab), Carboplatin, Paclitaxel

Interventions

M200 (Volociximab), Carboplatin, Paclitaxel DRUG

Volociximab will be administered via IV infusion at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels during the first cycle. Volociximab will be given for at least 6 cycles (3 weeks/cycle) and subjects who have stable disease at the end of 6 cycles may continue to receive volociximab alone until disease progression. Carboplatin is administered via IV infusion and dosed based on the Calvert formula (with a target area AUC of 6 mg/mL/min) for up to 6 cycles (3 weeks/cycle). Paclitaxel is administered via IV infusion and dosed at 200 mg/m2 for up to 6 cycles (3 weeks/cycle). All three drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin.

Also known as: Volociximab (M200)

1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females at least 18 years of age.
• Stage IIIB or IV or recurrent NSCLC.
• Measurable and/or evaluable disease according to RECIST.
• No prior chemotherapy, biological therapy or immunotherapy for Stage IIIB/IV disease. Adjuvant therapy for early stage disease must have been completed \> or = 6 months prior to Cycle 1, Day 1 of this study.
• Eastern Cooperative Oncology Group (ECOG) performance status \< or =1.
• A negative pregnancy test (serum or urine) in women of childbearing potential at screening.

You may not qualify if:

• Known allergy or sensitivity to murine proteins, chimeric antibodies or other components of the product, Cremophor EL (polyoxyethylated castor oil), cisplatin, or other platinum-containing compounds.
• Absolute neutrophil count (ANC) \<1500/mm3, hemoglobin level \<9 g/dL, or a platelet count \<100,000/mm3.
• Aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase values of .2.5 of the upper limits of normal values (ULN) (\>5 ULN for subjects with liver metastases) or alkaline phosphatase values \>2.5 ULN (unless documented bone metastases are responsible for the increase of alkaline phosphatase); total bilirubin \>1.5 mg/dL, or serum creatinine \>1.8 mg/dL.
• Radiation therapy within 1 month before Cycle 1, Day 1.
• Documented symptomatic central nervous system (CNS) tumor or CNS metastases.
• History of thromboembolic events, including cardiovascular or cerebrovascular events (ie, acute myocardial infarction \[AMI\], stroke) within 1 year prior to Cycle 1, Day 1.
• History of known bleeding disorders and coagulation defects.
• History of significant hemoptysis (ie, \> or =1/2 teaspoon red blood per event) or gastrointestinal bleeding within 1 year prior to Cycle 1, Day 1.
• Major surgery (eg, exploratory laparotomy) within 4 weeks prior to Cycle 1, Day 1 of the study.
• Clinically significant or unstable medical conditions including, but not limited to, uncontrolled diabetes mellitus requiring insulin, uncontrolled hypertension, or uncontrolled or symptomatic orthostatic hypotension.
• Oxygen-dependent chronic obstructive pulmonary disease.
• Known active infections requiring intravenous (IV) antibiotics, antivirals, or antifungals, including but not limited to chronic human immunodeficiency virus, hepatitis B, or hepatitis C infection.
• Prior bone marrow or stem cell transplant.

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Besse B, Tsao LC, Chao DT, Fang Y, Soria JC, Almokadem S, Belani CP. Phase Ib safety and pharmacokinetic study of volociximab, an anti-alpha5beta1 integrin antibody, in combination with carboplatin and paclitaxel in advanced non-small-cell lung cancer. Ann Oncol. 2013 Jan;24(1):90-6. doi: 10.1093/annonc/mds281. Epub 2012 Aug 16.

  PMID: 22904239 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms; Carcinoma

Interventions

volociximab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Mihail Obrocea, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 9, 2008
• Study Start: December 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 21, 2017

Record last verified: 2012-04