AzTrials
AzTrials

Lung CancerPhase 2NCT00293332

Docetaxel, Carboplatin, and Bevacizumab in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery

A Phase 2 study testing bevacizumab, carboplatin and docetaxel in people with Lung Cancer, run by University of California, San Francisco 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

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
bevacizumab, carboplatin and docetaxel
How many people
1 participants
Where
1 siteUnited States
Study dates
Dec 2005to Apr 2007
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer
  • No squamous cell carcinoma
  • No histology in close proximity to a major vessel
  • Resectable stage IB-IIIA disease
  • No CNS or brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Bilirubin normal
  • Creatinine ≤ 1.5 mg/dL
  • Urine protein:creatinine < 1.0
  • Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:
  • AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
  • AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
  • AP ≤ 5 times ULN AND AST and ALT normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment
  • Adequate pulmonary and cardiovascular function to tolerate surgical resection
  • No cavitation or history of hemoptysis (i.e., bright red blood ≥ ½ teaspoon)
  • No existing peripheral neuropathy ≥ grade 1
  • No known history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
  • No history of serious systemic disease, including any of the following:
  • Myocardial infarction within the past 6 months
  • Uncontrolled hypertension (i.e., blood pressure > 150/110 mm Hg on medication)
  • Unstable angina
  • New York Heart Association class II-IV congestive heart failure
  • Unstable symptomatic arrhythmia requiring medication
  • Patients with chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are eligible
  • Clinically significant peripheral vascular disease (i.e., grade II or higher)
  • No history of significant neurological or psychiatric condition
  • No known active infection within the past 14 days
  • No serious, nonhealing wound, ulcer, or bone fracture
  • No evidence of bleeding diathesis or coagulopathy
  • No stroke within the past 6 months
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No other serious illness or medical condition
  • No active infection
  • No other currently active malignancy except nonmelanoma skin cancer
  • Malignancies for which therapy has been completed and are considered to have ≤ 30% chance of risk of relapse are not considered active

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or VEGF inhibitor
  • No prior (i.e., within the past 4 weeks), concurrent, or anticipated participation in another experimental drug study except a Genentech-sponsored bevacizumab cancer study
  • No major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days
  • No anticipation for major surgical procedure during study treatment
  • No fine-needle aspiration or core biopsy within 7 days prior to study entry
  • No concurrent full-dose anticoagulation
  • No other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy for this cancer

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: A Phase II Study of Neoadjuvant Therapy With Docetaxel, Carboplatin, and Bevacizumab in Patients With Resectable Early Stage Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving docetaxel and carboplatin together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with bevacizumab works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the clinical response rate in patients with stage IB-IIIA non-small cell lung cancer treated with neoadjuvant docetaxel, carboplatin, and bevacizumab.

Secondary

  • Determine the median and overall survival of patients treated with this regimen.
  • Determine the safety profile of this regimen.
  • Determine the time to treatment failure of patients treated with this regimen.
  • Determine the pathologic response rate and the resectability rate in patients treated with this regimen.
  • Correlate vascular endothelial growth factor (VEGF) levels or expression with response and survival of patients treated with this regimen.

OUTLINE: Patients receive docetaxel IV over 15-60 minutes, carboplatin IV over 30-60 minutes, and bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Approximately 4-6 weeks after completion of chemotherapy, eligible patients with no distant or mediastinal disease progression undergo lobectomy, pneumonectomy, or segmentectomy with standard radical mediastinal lymph node dissection.

NOTE: *Bevacizumab is only administered during courses 1 and 2.

After completion of study treatment, patients are followed periodically for 8 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Conditions
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • bevacizumabBiological

    Also called Avastin

    Neoadjuvant therapy with 15 mg/kg, IV on Day 1 of each 21 day cycle for the first 2 cycles.

  • carboplatinDrug

    Also called Paraplatin

    Neoadjuvant therapy, AUC 6, IV on day 1 of each 21 day cycle for 3 cycles.

  • docetaxelDrug

    Also called Taxotere

    Neoadjuvant therapy, 75 mg/m2, IV on day 1 of each 21 day cycle for 3 cycles.

  • conventional surgeryProcedure or surgery

    Also called Resection

    Standard surgery after 3 cycles of neoadjuvant therapy with docetaxel, carboplatin, and bevacizumab. Bevacizumab is given for the first 2 cycles only.

What is being measured

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

  1. Clinical response rate by CT scan after 3 courses of induction treatment

    Measured: After 3 cycles of induction treatment

Secondary outcomes (10)
  1. Pathologic response rate after 3 courses of induction treatment

    Measured: After 3 cycles of induction treatment

  2. Resectability rate after 3 courses of induction treatment

    Measured: After 3 cycles of induction treatment

  3. Median survival at 2 years after surgery

    Measured: 2 years after surgery

  4. Safety after 3 courses of induction treatment

    Measured: After 3 cycles of induction treatment

  5. Overall survival at 2 years after surgery

    Measured: 2 years after surgery

  6. Time to treatment failure within 2 years after surgery

    Measured: 2 years after surgery

  7. Correlation of serum VEGF levels prior to neoadjuvant therapy with primary and secondary objectives prior to start of induction treatment

    Measured: Before induction treatment

  8. Correlation of serum VEGF expression in resected tumor with primary and secondary objectives

    Measured: After surgical removal of tumor

  9. Correlation of VEGF levels measured immediately after resection and after adjuvant bevacizumab therapy with primary and secondary objectives

    Measured: After resection and after adjuvant bevacizumab

  10. Assay additional downstream VEGF activation pathway markers

    Measured: At any time during the study

Timeline

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

  1. First posted17 Feb 2006 (estimated)
  2. Study startDec 2005
  3. Primary completionMar 2007
  4. Study completionApr 2007

Why it stopped: Terminated due to low subject 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00293332
Sponsor's protocol ID
CDR0000455640
Other IDs
UCSF-04652, UCSF-IIT-12198, UCSF-H5535-25047-01A
Status last verified
Jun 2007
First submitted
16 Feb 2006
Last updated
9 Feb 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, carboplatin and docetaxel in people with Lung Cancer, run by University of California, San Francisco 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?

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 9 Feb 2011. 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 was stopped early (reason given: Terminated due to low subject accrual). Results are not available in the source record.

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?

Clinical response rate by CT scan after 3 courses of induction treatment (time frame: After 3 cycles of induction treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 9 Feb 2011.

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