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Non-Small Cell Lung CancerPhase 1/2NCT00351039

Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in Elderly Patients With Non-Small Cell Lung Cancer

A Phase 1/2 study testing Bevacizumab, Erlotinib and Pemetrexed in people with Non-Small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a Phase I/II trial of elderly patients (> 70 years of age). Patients in this age group with previously un-treated Advanced Stage Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Bevacizumab, Erlotinib and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Jul 2006to Sep 2008
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patient must have histologically proven diagnosis of Non-Squamous NSCLC. NSCLC histologies that will be included in this trial will be adenocarcinoma, large cell carcinoma and adeno-squamous carcinoma. Patients with bronchioloalveolar carcinoma (BAC) will be also included in this trial.
  • Patients must be 70 years of age or older.
  • Patient must have either stage IIIB disease with malignant pleural effusion or stage IV disease. All patients must have measurable disease. Evaluable disease will be separately outlined and elucidated.
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1.
  • Patient must have adequate renal function with a serum creatinine level of less than 1.5mg/dl and patient should have a calculated creatinine clearance of more than 45ml/min.
  • Patient must have adequate hepatic function with a serum bilirubin level of less that 3mg/dl, and an alkaline phosphatase, Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) of less than three times the upper limit of normal
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  • Patient must also have evidence of adequate bone marrow function with an absolute neutrophil count of more than 1, 500 cells per deciliter and a platelet count of more than 100,000 per deciliter.
  • Patients must be more than 28 days since prior open biopsy; more than 7 days since prior fine-needle aspiration; more than 7 days since prior core biopsy; more than 28 days since prior surgery.
  • Patients must be able to take dexamethasone, folic acid and vitamin B-12 supplementation.
  • All patients must sign informed consent that will detail the investigational nature of the study in accordance with the institutional and federal guidelines.

Who cannot join

  • Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, with or without cavitation.
  • Patients with hypercalcemia (corrected calcium of more than 11 mg/dl) will be excluded.
  • Patients with history of hemoptysis, hematemesis, coagulopathy or thrombosis will be excluded.
  • Patients requiring anticoagulation for any reason will be excluded.
  • Patients who recently have an acute infection.
  • History of palliative radiation therapy within 2 weeks.
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  • Blood pressure of >150/100 Millimeter Mercury(mmHg).
  • Currently ongoing unstable angina.
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure.
  • History of myocardial infarction within 6 months.
  • History of stroke within 6 months.
  • Clinically significant peripheral vascular disease.
  • Presence of central nervous system or brain metastases.
  • 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 such as fine needle aspirations or core biopsies within 7 days prior to Day 0.
  • Pregnant (positive pregnancy test) or lactating.
  • Urine calculated creatinine clearance of less than 45ml/minute and a urinary protein. Creatinine ratio of more than 1.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Inability to comply with study and/or follow-up procedures.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase I/II Trial of Bevacizumab, Pemetrexed and Erlotinib in the First-Line Treatment of Elderly Patients With Advanced (Stage IIIB(With Malignant Pleural Effusion) or IV) Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

This is a Phase I/II trial of elderly patients (> 70 years of age). Patients in this age group with previously un-treated Advanced Stage Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled. Therapy consists of three drugs (Premetrexed[Alimta™], Bevacizumab and Erlotinib[Tarceva™]) which are given every 28 days.

Read the detailed description

This is a Phase I/II trial of elderly patients (> 70 years of age) with previously un-treated Advanced Stage Non-Squamous NSCLC with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled.

Treatment Regimen:

Premetrexed (Alimta™) 500 milligrams(mg)/Meter squared(m20 Intravenous(I.V.) Day 1 and Day 15; Bevacizumab 10mg/Kilogram(Kg) I. V. Day 1 and Day 15; Erlotinib (Tarceva™) 150mg Per Orally(PO) Once Daily(QD) for 7 days starting day 2 and day 15; Repeat cycles every 28 days.

All three drugs will be continued for two cycles after maximal response. After which patient will be maintained only on the Bevacizumab and Erlotinib until progression. If patient has stable disease after the first two cycles then patient will be given another two cycles with all three drugs before maintenance treatment with Bevacizumab and Erlotinib is initiated.

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.

  • BevacizumabDrug

    Also called Avastin

    Treatment Regimen Item 1: Bevacizumab 10 mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days.

  • ErlotinibDrug

    Also called Tarceva

    Treatment Regimen Item 2: Erlotinib 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days.

  • PemetrexedDrug

    Also called Alimta

    Treatment Regimen Item 3: Premetrexed 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days.

Study groups in NCT00351039
Study groupRoleWhat they receive
Bevacizumab, Erlotinib, PemetrexedExperimentalSingle Arm Phase II trial in elderly patients with advanced stage Non-Squamous Non-Small Cell Lung Cancer
Receives: Drug: Bevacizumab; Drug: Erlotinib; Drug: Pemetrexed

What is being measured

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

  1. Progression Free Survival (PFS)

    The primary objective was to determine the progression free survival (PFS), in newly diagnosed patients with advanced Non Small Cell Lung Cancer (NSCLC) who are treated with a regimen consisting of Bevacizumab(B), pemetrexed(A), and erlotnib(T). This was a Phase I/II study. This trial was halted after the Phase I component was completed. The Phase II component was never initiated.

    Measured: 26 months

Secondary outcomes (5)

  1. One-year Survival(1-year S)

    Secondary Objective: One-year survival(1-year S) in patients with advanced NSCLC treated with this regimen.

    Measured: 26 Months

  2. Number of Patients Who Responded to Treatment

    Phase I:

    Response Evaluation Criteria In Solid Tumors (RECIST)Criteria was used for Response. Partial Response (PR) is defined as at least a 30% decrease in the sum of Longest Dimention (LD) of target lesions taking as reference the baseline sum LD.

    Measured: 26 Months

  3. Quality of Life (QOL)

    The Scales we were intending to use were:

    Instrumental Activities of Daily Living (IADL): Range of Scale 0 (Best) to 8 (Worst).

    Cumulative Illness Rating Scale-Geriatric (CIRS-G): Range of Scores 1(Best) to 18 (Worst).

    Functional Assessment of Cancer Therapy-Lung (FACT-L): Range of Scores 0 (Best) to 48 (Worst).

    Fatigue Symptom Inventory (FSI): Range of Scores 0(Best) to 121 (Worst).

    Each scale would have been evaluated independently. Since the study was not completed and closed early due to poor accrual, none of the QOL parameters were analyzed.

    Measured: 26 Months

  4. Number of Participants With Grade 3 and Grade 4 Adverse Events

    By Safety, the intent was to capture, tabulate, list all of the grade 3 and 4 adverse effects seen by this protocol. For each toxicity, we followed the Common Toxicity Criteria(NCI CTC)Version 2.0 Toxicity scale guidelines.

    Measured: 26 Months

  5. Overall Survival (Median Survival [MS])

    Secondary Objective: Determine the Overall Survival (median survival[MS]) in patients with advanced NSCLC treated with this regimen. Patients were to be followed until death and survival curves were to be generated.

    Measured: 26 Months

Timeline

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

  1. First posted12 Jul 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionSep 2008
  4. Study completionSep 2008

Why it stopped: slow accrual

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00351039
Sponsor's protocol ID
MCC-14659
Status last verified
Aug 2010
First submitted
11 Jul 2006
Last updated
23 Mar 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bevacizumab, Erlotinib and Pemetrexed in people with Non-Small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 10 inclusion and 20 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: stopped early, as of the sponsor's last update on 23 Mar 2017. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 30 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival (PFS) (time frame: 26 months). 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 NCT00351039.

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 23 Mar 2017.

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