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Non-Small Cell Lung CancerPhase 2NCT00251524

A Phase II Study of Eloxatin and Alimta in Combination With Bevacizumab in Advanced Non-Squamous NSCLC

A Phase 2 study testing Bevacizumab, Oxaliplatin, Pemetrexed in people with Non-Small Cell Lung Cancer, run by Veeda Oncology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase II, open-label, non-randomized study in patients with advanced non-squamous NSCLC. Each cycle will be 21 days. Patients will be evaluated every 2 cycles (~6 weeks) for response using RECIST criteria. Those patients achieving stable disease or better will continue therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Bevacizumab, Oxaliplatin, Pemetrexed
Type of treatment
Injection or infusion
How many people
69 participants
Where
1 siteUnited States
Study dates
Nov 2005to May 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be eligible for the study, patients must fulfill all of the following criteria:
  • Patients or their legal representatives must be able to read and understand, and must have signed an IRB-approved informed consent to participate in the trial.
  • Patients may have measurable or non-measurable disease based on RECIST criteria. Tumor lesions that are situated in a previously irradiated area are not considered measurable.
  • Patients must have histologically documented Stage IIIB/IV non-squamous cell NSCLC.
  • Patients must have an ECOG Performance Status of 0 or 1.
  • Patients must be >18 years of age.
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  • Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months.
  • Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for 90 days after receiving last study treatment.
  • Patients must have white blood cell (WBC) >3,000/µL, absolute neutrophil count (ANC) >1,500/µL, platelets >100,000/µL, and hemoglobin >9g/dL.
  • Calculated creatinine clearance (CrCl) <45mL/min based on the standard Cockroft and Gault formula.
  • Patients must have a serum creatinine <1.5 x institutional upper limit of normal (ULN).
  • Patients must have a bilirubin <1.5 x ULN, an ALT or AST <3 x ULN, and an alkaline phosphatase <3 x ULN. For patients with liver metastases, ALT, AST, and alkaline phosphatase levels can be <5 x ULN.
  • Patients must have INR <1.5, and PTT <ULN within 1 week prior to registration.
  • Urine Protein: Creatinine ratio must be < 1.0.

Who cannot join

  • Any of the following criteria will make the patient ineligible to participate in this study:
  • Prior chemotherapy or biologic therapy, including prior treatment with Bevacizumab, for the treatment of non-squamous NSCLC.
  • Patients with squamous cell NSCLC.
  • Patients with any histology in close proximity to a major vessel, cavitation, or history of hemoptysis (bright red blood of 1/2 teaspoon or more).
  • Patients who have a history of hypersensitivity to Eloxatin (or other platinum components), Alimta, or Bevacizumab or any of the components in these drugs.
  • Patients who have undergone major surgery, open biopsy, or significant traumatic injury within 28 days prior to registration or anticipation of need for major surgical procedure during the course of the study.
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  • Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to registration.
  • Patients who received radiotherapy to more than 25% of their bone marrow; patients who received any radiotherapy within 4 weeks of registration, or previous radiation to the only area of measurable disease.
  • Blood pressure of >150/100 mmHg, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (Appendix IV), or a history of myocardial infarction or stroke within 6 months.
  • Clinically significant peripheral vascular disease or evidence of bleeding diathesis (prone to bleeding), or coagulopathy.
  • Patients on therapeutic anticoagulation. (Prophylactic anticoagulation of venous access devices is allowed.)
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • History of allogeneic transplant.
  • Known HIV or Hepatitis B or C (active, previously treated, or both).
  • Patients planning to receive any concurrent therapy to treat NSCLC during the study treatment period.
  • Patients must not be receiving chronic daily treatment with Aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory agents known to prohibit platelet function. Treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), or cilostazal (Pletal) is also not allowed.
  • Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication).
  • Patients with a serious uncontrolled intercurrent medical or psychiatric illness, including an active infection, or a fever > 38.5°C within 3 days of the first scheduled day of study treatment.
  • Patients with a history of other malignancy within the last 5 years, with the exception of low grade prostate cancer (Gleason Grades 1-4), non melanoma skin cancer, or carcinoma in situ of the cervix, which could affect the diagnosis or assessment of these study drugs for NSCLC. Patients treated more than 5 years ago for a malignancy other than non-squamous NSCLC are eligible.
  • Patients with brain metastases or leptomeningeal disease.
  • Any patient who is pregnant or lactating.
  • Any patient who is unable to comply with requirements of study.
  • Patients with peripheral neuropathy >grade 1.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Veeda Oncology

    Columbus, Ohio, 43215

Other trials in United States

About this study

This is a Phase II, open-label, non-randomized study in patients with advanced non-squamous NSCLC.

Each cycle will be 21 days. Patients will be evaluated every 2 cycles (~6 weeks) for response using RECIST criteria. Those patients achieving stable disease or better will continue therapy. Those patients experiencing progressive disease will be taken off study.

Read more

Patients will receive 6 cycles of Eloxatin, Alimta, and Bevacizumab. After the 6 cycles, patients will receive Bevacizumab alone every 21 days until evidence of disease progression or unacceptable toxicity.

Note: Once patient has completed the 6 cycles of Eloxatin, Alimta, and Bevacizumab and is receiving single-agent Bevacizumab, assessment of response will be performed every 3 cycles (~every 9 weeks) using RECIST criteria.

Being tested
Bevacizumab, Oxaliplatin, Pemetrexed
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab, Oxaliplatin, PemetrexedDrug

    Also called Avastin

    Avastin 15 mg/kg IV, Alimta 500 mg/m2 IV given over 10 minutes, Eloxatin 120 mg/m2 IV given over 2 hours

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the median progression-free survival in patients with advanced non-squamous non-small cell lung cancer (NSCLC) receiving Eloxatin and Alimta in combination with Bevacizumab as first-line treatment

    Measured: unk

Secondary outcomes (3)

  1. To evaluate the median and the 1-year and 2-year survival in patients with advanced NSCLC receiving Eloxatin and Alimta in combination with Bevacizumab as first-line treatment.

    Measured: unk

  2. To determine the overall objective response and the duration of response in patients with advanced NSCLC receiving Eloxatin and Alimta in combination with Bevacizumab as first-line treatment.

    Measured: unk

  3. To evaluate the safety of Eloxatin and Alimta in combination with Bevacizumab in patients with advanced NSCLC as first-line treatment.

    Measured: unk

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionMay 2009
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251524
Sponsor's protocol ID
I-04-015
Status last verified
May 2012
First submitted
8 Nov 2005
Last updated
11 May 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Oxaliplatin, Pemetrexed in people with Non-Small Cell Lung Cancer, run by Veeda Oncology at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the median progression-free survival in patients with advanced non-squamous non-small cell lung cancer (NSCLC) receiving Eloxatin and Alimta in combination with Bevacizumab as first-line treatment (time frame: unk). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00251524.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2012.

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