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A Phase II Trial of Carboplatin, Bevacizumab and Pemetrexed in Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Non Small Cell Lung Cancer

Thank you

Trial Information

A Phase II Trial of Carboplatin, Bevacizumab and Pemetrexed in Advanced Non-Small Cell Lung Cancer

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

efficacy of a novel combination of Carboplatin, Pemetrexed and Bevacizumab used concurrently in the treatment of NSCLC

Outcome Time Frame:

CT scans to determine evaluation of response after 2 cycles of treatment

Safety Issue:


Principal Investigator

Michael Guarino, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Christiana Care Health Services


United States: Institutional Review Board

Study ID:




Start Date:

November 2007

Completion Date:

June 2013

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms