Ph II of Vinflunine and Cetuximab in Second Line Treatment of NSCLC

NCT00519831 | Terminated Phase 2 Results DMC

• 1 other identifier: UNC LCCC 0503
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as vinflunine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Giving vinflunine together with cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vinflunine together with cetuximab works as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Overall Tumor Response Rate as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Sum of Partial Responses (PR) and Complete Responses (CR).

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement.

  Baseline, after cycle 2, within 2 weeks of completing cycle 4

Secondary Outcomes (3)

• Duration of Response

  After cycle 4

• Overall Survival

  Every 30 days

• Progression-free Survival

  after cycle 2, within 2 weeks of completing cycle 4

Study Arms (1)

Vinflunine + Cetuximab

EXPERIMENTAL

Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.

Biological: cetuximab; Drug: vinflunine

Interventions

cetuximab BIOLOGICAL

400 mg/m² week 1,then 250 mg/m² weekly

Also known as: erbitux

Vinflunine + Cetuximab

vinflunine DRUG

Vinflunine 320 mg/m² every 21 days

Also known as: Javlor

Vinflunine + Cetuximab

Eligibility Criteria

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

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Absolute neutrophil count (ANC) \> 1,000/mm³
• Hemoglobin \> 8.0 g/dL
• Platelet count \> 75,000/mm³
• Creatinine \< 2.0 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 times ULN
• Total bilirubin \< 2.5 times ULN
• Prior malignancy allowed provided the patient's life expectancy is best defined by the diagnosis of NSCLC
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for up to 4 weeks after completion of study therapy

You may not qualify if:

• Peripheral neuropathy ≥ 2
• Severe allergic reaction to prior vinca alkaloid treatment
• Active or uncontrolled infection
• Significant history of uncontrolled cardiac disease, including any of the following:
• Uncontrolled hypertension
• Unstable angina
• Myocardial infarction within the past 6 months
• Uncontrolled congestive heart failure
• Cardiomyopathy with decreased ejection fraction
• Severe reaction to prior monoclonal antibody therapy
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Prior oral tyrosine kinase inhibitor therapy (e.g. gefitinib or erlotinib) allowed
• Not considered cytotoxic therapy for study eligibility purposes if given alone as first-line therapy
• At least 1 week since prior radiotherapy

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (2)

Alamance Oncology/Hematology Associates, LLP

Burlington, North Carolina, 27216, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab; vinflunine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Study was terminated early due to unavailable drug/funding. Preliminary analysis reported.

Results Point of Contact

• Title: Robin V. Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

Robin_V_Johnson@med.unc.edu

919-966-1125

Study Officials

• Thomas E. Stinchcombe, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 21, 2007
• First Posted: August 23, 2007
• Study Start: August 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: November 1, 2009
• Last Updated: June 9, 2017
• Results First Posted: June 9, 2017

Record last verified: 2017-05

Locations

US (2)