Carboplatin, Bevacizumab and Pemetrexed in Advanced Non Small Cell Lung Cancer

NCT00614822 | Completed Phase 2 Results DMC

• 2 other identifiers: 24091Eli Lilly H3E-US-X072
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to look for an improvement in progression free survival with the combination of bevacizumab, carboplatin and pemetrexed in patients with newly diagnosed advanced/metastatic non small cell lung cancer. Overall survival and safety will also be assessed.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").

• Overall Survival

  Overal survival was defined as time between the date of treatment assignment and the date of death

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").

Secondary Outcomes (2)

• Number of Participants With Complete and Partial Tumor Responses

  Patients were enrolled over a 24 month period for treatment visits. After end of treatment visits, subjects were seen or contacted every 3 months for survival data. Median follow up was 49 weeks (6 weeks to death.

• Number of Participants With Adverse Events

  Subjects were seen or contacted every 3 months with medain follow up of 49 weeks.

Study Arms (1)

one arm for study

OTHER

Carboplatin, Pemetrexed and Bevacizumab are given day 1 every 3 weeks for 6 cycles and will be continued if patient tolerates treatments and has stable disease. The Bevacizumab will be continued every 3 weeks for 1 year if the patient tolerates treatment and has stable disease.

Drug: Carboplatin, Pemetrexed and Bevacizumab

Interventions

Carboplatin, Pemetrexed and Bevacizumab DRUG

Carboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles

Also known as: Paraplatin, Alimta, Avastin

one arm for study

Eligibility Criteria

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

You may qualify if:

• Advanced stage NSCLC (IIIB with malignant pleural effusion; T4 \[on basis on satellite lesion\] N2, 3; or stage IV) excluding squamous cell histology, with measurable or evaluable disease.
• Prior chemotherapy therapy for early stage disease with one regimen is acceptable if it was completed at least 6 months prior to study entry.
• Palliative radiotherapy to painful bony metastases will be permitted prior to study entry if completed prior to initiation of study treatment, and there are no residual sequelae of therapy such as bone marrow suppression.
• Life expectancy of at least 3 months.
• ECOG Performance status 0-1.
• Age 18 or higher.
• Willingness to use appropriate contraception to avoid pregnancy during the study (female patient or female partner of a male patient)
• Patients must have normal organ and marrow function as defined below:
• leukocytes greater than or equal to3,000/µl ANC greater than or equal to 1,500/µl platelets greater than or equal to 100,000/µl total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance ≥ 45 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
• Ability to sign informed consent
• Ability to take folic acid, Vitamin B12 and dexamethasone as per protocol
• Ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta.

You may not qualify if:

• Patients meeting any of the following criteria are ineligible for study entry:
• Prior cytotoxic treatment for advanced NSCLC. One prior regimen (up to 4 cycles) of neoadjuvant or adjuvant therapy for early stage disease will be allowed if completed at least 6 months prior to study entry.
• Prior definitive chest irradiation (radiation of rib or spine mets permitted)
• Known brain metastases (unless previously resected and radiated)
• Prior treatment with bevacizumab or pemetrexed
• History of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to bevacizumab or carboplatin
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study.
• Concomitant chemotherapy, radiotherapy or investigational agents.
• Evidence of bleeding diathesis or coagulopathy.
• Use of anti-coagulant agents warfarin (1mg, by mouth, daily for port maintenance permitted), heparin (ASA, NSAID permitted).
• Pregnant (positive pregnancy test) or lactating women.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study.
• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0.
• Urine protein creatinine ratio 1.0 at screening. -History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 6 months prior to Day 0.
• Serious, non-healing wound, ulcer, or bone fracture.

Sponsors & Collaborators

• Christiana Care Health Services: lead
• Eli Lilly and Company: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Pemetrexed; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Limitations and Caveats

include the absence of randomization, lack of independent radiology review and small sample size

Results Point of Contact

• Title: Dr. Michael Guarino
• Organization: Christiana Care Health System

mguarino@cbg.org

302 366 1200

Study Officials

• Michael Guarino, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: January 30, 2008
• First Posted: February 13, 2008
• Study Start: November 1, 2007
• Primary Completion: August 22, 2016
• Study Completion: August 22, 2016
• Last Updated: March 20, 2019
• Results First Posted: March 20, 2019

Record last verified: 2019-03