Carboplatin, Bevacizumab and Pemetrexed in Advanced Non Small Cell Lung Cancer (H3E-US-X072)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00614822
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : October 23, 2017
Eli Lilly and Company
Information provided by (Responsible Party):
Christiana Care Health Services

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Carboplatin, Pemetrexed and Bevacizumab Phase 2

Detailed Description:

Carboplatin: AUC 5 IV over 30-60 minutes on day 1 Pemetrexed: 500mg/M2 IV over 10 minutes on day 1 Bevacizumab: 15mg/kg IV over 90 minutes on day 1 (if rate is tolerated the 2nd dose may be decreased to 60 minutes and subsequent doses to 30 minutes This regimen will be administered every 6 weeks for up to a maximum of 6 cycles if the patient tolerates the treatment and has stable disease. Bevacizumab will be continues if tolerated for up to 1 year at every 3 week intervals.

Folic acid 1mg by mouth daily, Vitamin B12 1000 ug IM every 9 weeks and Dexamethasone 4mg by mouth twice a day and and antiemetic may be prescribed by the physician investigator to help reduce side effects associated with the Pemetrexed. The Folic acid and Vitamin B12 will continue until 3 weeks after the end of treatment.

Physical exams, vital signs and blood work will be done prior to each chemotherapy cycle. A urine dipstick to check for protein in the urine will be done prior to the first treatment and before cycles 3 and 5. A CAT scan of the chest will be done pretreatment, prior to cycles 3 and 5 and at the end of treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Carboplatin, Bevacizumab and Pemetrexed in Advanced Non-Small Cell Lung Cancer
Study Start Date : November 2007
Actual Primary Completion Date : August 22, 2016
Actual Study Completion Date : August 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
one arm for study
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
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
Other Names:
  • Paraplatin
  • Alimta
  • Avastin

Primary Outcome Measures :
  1. efficacy of a novel combination of Carboplatin, Pemetrexed and Bevacizumab used concurrently in the treatment of NSCLC [ Time Frame: CT scans to determine evaluation of response after 2 cycles of treatment ]

Secondary Outcome Measures :
  1. assessment of treatment tolerability measured by adverse events such as grade 4 toxicities, hospitalizations for toxicities, fever and neutropenia events and clinically significant bleeding/thrombotic events [ Time Frame: will document all adverse experiences after the start of the study and will follow up subjects until event has disappeared or condition stabilized ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion criteria

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.
  • Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, or with significant cavitation as assessed by treating investigator in consultation with an attending radiologist. -Recent history of hemoptysis (bright red blood of 1/2 teaspoon or more)- within one month of study entry
  • Significant co-morbidities including:

Blood pressure of 150/100 mmHg Unstable angina New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix B) History of myocardial infarction within 6 months History of stroke within 6 months Clinically significant peripheral vascular disease

  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Another active malignancy except for non-melanoma skin cancers.
  • Clinically significant pleural, pericardial, and/or peritoneal effusions unless drained or controlled prior to study entry.
  • Undrainable, clinically relevant effusions and presence of third space fluid which cannot be controlled by drainage.
  • Hepatic impairment as evidenced by Bilirubin greater than 1.5 times the upper limit of normal Transaminases greater than 3.0 times limit of normal (ULN), except in presence of known hepatic metastasis, wherein may be up to 5 times ULN
  • Any CTCAE Version 3.0 Grade 3 or 4 non hematologic toxicity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00614822

Sponsors and Collaborators
Christiana Care Health Services
Eli Lilly and Company
Principal Investigator: Michael Guarino, MD Christiana Care Health Services

Responsible Party: Christiana Care Health Services Identifier: NCT00614822     History of Changes
Other Study ID Numbers: 24091
Eli Lilly H3E-US-X072
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Bronchial Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors