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Non-Small Cell Lung CancerPhase 2NCT00271505

Avastin/Docetaxel/Carboplatin in Non-Small Cell Lung Cancer

A Phase 2 study testing Bevacizumab (Avastin), Carboplatin and Docetaxel in people with Non-Small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 2 sites 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

The goal of this clinical research study is to evaluate the effectiveness of Avastin® in combination with docetaxel and carboplatin in the treatment of lung cancer. The safety of this combination will also be studied. 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 (Avastin), Carboplatin and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
2 sitesUnited States
Study dates
5 Dec 2005to 27 Jul 2017
Phase
Phase 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women, at least 18 years old, with histologically confirmed, advanced stage IIIB or IV NSCLC for whom no curative options exist and for whom docetaxel and carboplatin is a reasonable treatment option;
  • At least 1 target lesion that is unidimensionally measurable as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) and has not been previously irradiated;
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1, (determined within 2 weeks prior to receiving study medication;
  • Ability to understand and adhere to the protocol requirements, and give informed consent
  • Use of effective means of contraception (men and women) in subjects of child-bearing potential. Child-bearing potential is defined as follows: A woman of childbearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses at any time in the preceding 12 consecutive months).

Who cannot join

  • Patients who have had docetaxel in nonradiosensitizing therapy
  • Patients who have received prior full dose systemic chemotherapy for NSCLC (ie neoadjuvant, adjuvant, or metastatic) within the last 6 months.
  • Eastern Cooperative Oncology Group (ECOG) status of 2 or greater
  • Screening clinical laboratory values:*absolute neutrophil count (ANC) of <1,500/µL *Platelet count of <75,000/µL * international normalized ratio (INR) >/= 1.5 *T bilirubin elevation above normal (MDACC upper normal limit is 1.0 mg/dL) *Serum creatinine of >2.0 mg/dL *Hemoglobin of <9 mg/dL (may be transfused or receive epoetin alfa [e.g., Epogen®] to maintain or exceed this level) *The pt is ineligible if: 1.alk phos>5xULN; 2.AST or ALT >5xULN; 3.alk phos >1xULN but </= 2.5xULN AND AST or ALT >1.5xULN but </=5xULN;4.alk phos >2.5xULN but </=5xULN AND AST or ALT > 1xULN but</= 1.5xULN; 5.alk phos >2.5xULN but</=5xULN AND AST or ALT >1.5xULN but </=5xULN
  • Inability to comply with study and/or follow-up procedures
  • History of other disease, active infection, metabolic dysfunction , physical examination finding, or clinical laboratory finding which is uncontrolled requiring medical intervention giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
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  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a bevacizumab cancer study
  • Prior exposure to anti-VEGF therapy
  • Blood pressure of > 140/90 mmHg as documented in two consecutive blood pressure readings within 4 hours
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months
  • History of stroke or transient ischemic attack within 6 months
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • Evidence of bleeding diathesis or coagulopathy
  • Presence of central nervous system or brain metastases at any time
  • 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
  • Pregnant (positive pregnancy test) or lactating
  • Proteinuria at screening as demonstrated by either: Urine protein:creatinine (UPC) ratio > 1.0 at screening OR Urine dipstick for proteinuria > 2+ (patients discovered to have > 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate < 1g of protein in 24 hours to be eligible).
  • 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, cavitation.
  • History of hemoptysis (bright red blood of 1/2 teaspoon or more)
  • Full dose anticoagulation, chronic use of Aspirin (>325 mg/day) or NSAIDs
  • Inability to comply with study and/or follow-up procedures

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Lyndon Baines Johnson General Hospital

    Houston, Texas, 77030

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase II Evaluation of Avastin in Combination With Docetaxel and Carboplatin as Chemotherapy in Patients With Metastatic Non-Small Cell Lung Cancer

The goal of this clinical research study is to evaluate the effectiveness of Avastin® in combination with docetaxel and carboplatin in the treatment of lung cancer. The safety of this combination will also be studied.

Read the detailed description

Avastin® is a humanized monoclonal antibody that binds to vascular endothelial growth factor (VEGF). VEGF plays an important role in the growth of both normal and abnormal blood vessels. Avastin® is designed to prevent or slow down the growth of cancer cells by blocking the effects of VEGF.

Docetaxel and carboplatin are standard chemotherapy drugs that have been approved by the FDA for the treatment of NSCLC. Docetaxel and carboplatin are designed to work by stopping the division of cancer cells.

If you are found to be eligible, you will begin receiving Avastin®, docetaxel, and carboplatin. Avastin®, carboplatin, and docetaxel will be given by vein once every 3 weeks. The first dose of Avastin® will be given over 90 minutes. The second dose of Avastin® will be given over 60 minutes. All other doses of Avastin® will be given over 30 minutes. Carboplatin and docetaxel will always be given over 30 minutes. They will be given on the same day every 3 weeks (1 cycle). You may receive up to 6 cycles of treatment. You will receive standard premedication with dexamethasone to help decrease the risk of side effects. Dexamethasone will be taken before you receive your docetaxel infusion.

During the study, you will have blood tests (about 2 teaspoons) every 3 weeks to look at your blood counts. These samples will be used only for routine lab tests. You will be seen by a physician every 3 weeks and given a physical exam. Your blood pressure will be monitored, and you will be asked about any side effects you are experiencing. A performance status evaluation will also be done. In addition, you will have a urine test every 2 cycles of treatment.

After 2 cycles of treatment (6 weeks), you will have a chest x-ray and computerized tomography (CT) or magnetic resonance imaging (MRI) scan to evaluate the status of the disease. These will be repeated every 2 cycles. Your continued participation in this study depends on how your cancer responds to the study drugs. Your doctor may decide to take you off this study if you experience significant side effects or your medical condition worsens. You may continue receiving bevacizumab for as long as your cancer responds to study treatment.

You will be followed-up on by phone or at routine clinic visits for at least 12 months to monitor your condition and disease status.

This is an investigational study. Avastin® has been approved by the FDA for the treatment of colorectal cancer. Docetaxel and carboplatin are FDA approved and commercially available. The use of these drugs together in this study is experimental. A total of 50 patients will take part in this study. All participants will be enrolled at M. D. Anderson.

Being tested
Bevacizumab (Avastin), Carboplatin, Docetaxel
Keywords
Non-Small Cell Lung Cancer, Lung Cancer, Bevacizumab, Carboplatin, Docetaxel, Avastin, NSCLC, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, Paraplatin®, Taxotere
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

  • Bevacizumab (Avastin)Drug

    Also called Anti-VEGF monoclonal antibody, rhuMAb-VEGF

    15 mg/kg intravenously (IV) every 3 weeks

  • CarboplatinDrug

    Also called Paraplatin®

    AUC 6 IV every 3 weeks

  • DocetaxelDrug

    Also called Taxotere

    75 mg/m2 IV every 3 weeks

Study groups in NCT00271505
Study groupRoleWhat they receive
Avastin + Docetaxel + CarboplatinExperimentalAvastin 15 mg/kg intravenously (IV) every 3 weeks. Docetaxel 75 mg/m2 IV every 3 weeks. Carboplatin AUC 6 IV every 3 weeks.
Receives: Drug: Bevacizumab (Avastin); Drug: Carboplatin; Drug: Docetaxel

What is being measured

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

  1. Time to Progression-Free Survival (PFS)

    Bevacizumab has recently been demonstrated to prolong overall survival when added to carboplatin and paclitaxel for chemotherapy-naı¨ve patients with nonsquamous nonsmall-cell lung cancer (NSCLC). However, the effects of combining bevacizumab with other standards, front-line, platinum-based doublets have not been extensively explored.We designed this single treatment arm, phase 2 trial to determine whether the combination of carboplatin, docetaxel, and bevacizumab is tolerable and prolongs progression-free survival of chemotherapy-naı¨ve patients with advanced, on squamous NSCLC.

    Measured: Baseline up to 12 months or disease progression/death

Secondary outcomes (2)

  1. Overall Survival (OS)- 5 Years

    Secondary endpoints of the study included the assessment of overall survival, disease control rate (CR þPR þ SD, defined by RECIST16), and evaluation of the safety profile of this triple-agent regimen. All patients who received at least 1 dose of the study drug were analyzed for efficacy and toxicity endpoints.

    Measured: Baseline start of treatment to death, assessed up to 6 years

  2. Disease Control Rate

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1 .0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)= CR+ PR.

    Measured: Baseline start of treatment to death, assessed up to 6 years

Timeline

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

  1. First posted2 Jan 2006 (estimated)
  2. Study start5 Dec 2005
  3. Primary completion27 Jul 2017
  4. Study completion27 Jul 2017

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
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00271505
Sponsor's protocol ID
2005-0224
Other IDs
NCI-2012-01621
Status last verified
Apr 2020
First submitted
29 Dec 2005
Last updated
11 May 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab (Avastin), Carboplatin and Docetaxel in people with Non-Small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 2 sites 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 5 inclusion and 26 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 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 11 May 2020). 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?

Time to Progression-Free Survival (PFS) (time frame: Baseline up to 12 months or disease progression/death). 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 NCT00271505.

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 2020.

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