AzTrials
AzTrials

Non-small Cell Lung CancerPhase 2NCT00378573

Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase 2 study testing docetaxel, gemcitabine and bevacizumab in people with Non-small Cell Lung Cancer, run by Sanofi at 1 site in United States.

Terminated

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

Official record
Search all trials

Trial summary

This is a Phase II prospective, multicenter study evaluating Progression Free Survival (PFS) after first line treatment with the combination of gemcitabine, docetaxel, and bevacizumab in subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). 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?
docetaxel, gemcitabine and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
Jan 2007to Sep 2008
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

  • Histologic or cytologic confirmation of locally advanced (pleural effusion) or metastatic (Stage IIIB/IV) NSCLC (non-squamous-cell histology only), mixed tumor types can be selected based on predominant cell type unless small cell elements are discovered (in which case the subject is not eligible);
  • Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 20 mm with conventional computerized tomography (CT) or magnetic resonance imaging (MRI) scans, or as >/= 10 mm with spiral computerized tomography (CT) scan
  • No previous systemic chemotherapy
  • Estimated life expectancy of >/= 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
  • Nonpregnant, nonlactating female subjects; male and female subjects of childbearing potential must be willing to use an effective form of contraception while on therapy and for 90 days thereafter; an effective form of contraception is defined as an oral contraceptive or a double barrier method; pregnancy is to be determined/ ruled out through the use of serum human chorionic gonadotropin (HCG)
Show all 9Show fewer
  • Subjects must have adequate renal function as determined by the following within 1 week prior to study registration: Calculated creatinine clearance >45 mL/min using Cockcroft-Gault formula; Urine protein: creatinine (UPC) ratio <1.0 by spot urinalysis; Urine dipstick for protein <2+ (subjects discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate </= 1 g of protein in 24 hours to be eligible);
  • Hematologic evaluation within 2 weeks prior to study registration (minimum values): Absolute neutrophil count (ANC) >/= 1500 mm3; Platelet count >/= 100,000 mm3; Hemoglobin (Hg) >/= 9.9 g/dL (erythropoietin may be transfused to maintain or exceed this level); Partial thromboplastin time (PTT) no greater than upper limit of normal (ULN)
  • Hepatic function evaluation within 2 weeks prior to study registration (as detailed in protocol provided to Investigator): Total bilirubin </= upper limit of normal; Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase must be within the range allowing for eligibility; In determining eligibility the more abnormal of the two values (AST or ALT) should be used (details for decision in full protocol as provided to Investigator)

Who cannot join

  • Receipt of prior systemic chemotherapy, vascular endothelial growth factor (VEGF) or endothelial growth factor receptor (EGFR) inhibitor therapy at any time; receipt of recent or current radiation therapy; current, recent (within 4 weeks prior to study registration), or planned receipt of investigational therapy (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
  • Subjects with cardiovascular diseases and related treatments
  • Surgical procedure in anamnesis (medical history): Major surgical procedure, 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; Minor surgical procedures (eg, fine needle aspirations, core biopsies) within 7 days prior to registration;
  • Serious non-healing wound, ulcer, or bone fracture;
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study registration;
  • History of gross hemoptysis (defined as bright red blood of >/= 0.5 teaspoon)
Show all 12Show fewer
  • History of hypersensitivity reaction to drugs formulated with polysorbate 80;
  • Subjects with brain metastases;
  • Peripheral neuropathy >/= Grade 2 (based on Common Toxicity Criteria Adverse Event [CTCAE] v3.0);
  • History of a malignancy other than NSCLC; exceptions to this include: Curatively treated basal cell carcinoma; cervical intraepithelial neoplasia; or localized prostate cancer with a current prostate-specific antigen (PSA) of <1.0 ng/dL on 2 successive evaluations at least 3 months apart, and the most recent evaluation within 4 weeks of study registration; History of another malignancy that was curatively treated and no evidence of disease for a minimum of 5 years;
  • Symptoms of a clinically meaningful illness in the 90 days before the study, or history of other disease, (such as human immunodeficiency virus (HIV) positive, chronic infection (eg, pulmonary tuberculosis), or hepatitis A, B or C (active or previously treated), active infection with fever, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that might affect the interpretation of the results of the study, or render the subject at high risk from treatment complications; (testing for these conditions will be at investigator discretion)
  • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sanofi-Aventis Administrative Office

    Bridgewater, New Jersey

Other trials in United States

About this study

Official title: A Phase II, Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This is a Phase II prospective, multicenter study evaluating Progression Free Survival (PFS) after first line treatment with the combination of gemcitabine, docetaxel, and bevacizumab in subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). PFS will be measured from the date of registration (ie, assignment of subject number when subject meets all entry criteria) to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurs first.

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.

Study groups in NCT00378573
Study groupRoleWhat they receive
docetaxel, gemcitabine and bevacizumabExperimentalSingle arm treatment with docetaxel, gemcitabine and bevacizumab
Receives: Drug: docetaxel; Drug: gemcitabine; Drug: bevacizumab

What is being measured

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

  1. Progression Free Survival for Subjects With Locally Advanced or Metastatic (Stage IIIB or Stage IV) Non-Small Cell Lung Cancer (NSCLC) After Systemic Treatment With Gemcitabine, Docetaxel, and Bevacizumab as First Line Therapy

    Measured: 1 year post-registration

Secondary outcomes (2)

  1. Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST)

    Complete response is defined as disappearance of all target and nontarget lesions identified and reported at baseline (at or within 4 weeks before the beginning of treatment) by image-based evaluations such as computerized tomography (CT) or magnetic resonance imaging (MRI).

    Partial response is defined as persistence of one or more nontarget lesions and at least 30 percent decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.

    Measured: 1 year from start of treatment

  2. Overall Survival

    Survival is defined as the time from the date of registration to the study to the date of death.

    Measured: 2 years post-registration

Timeline

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

  1. First posted20 Sep 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionSep 2008
  4. Study completionSep 2008

Why it stopped: Incidence of GI Perforation

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00378573
Sponsor's protocol ID
DOCET_L_00730
Status last verified
Jan 2010
First submitted
19 Sep 2006
Last updated
26 Jan 2010

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel, gemcitabine and bevacizumab in people with Non-small Cell Lung Cancer, run by Sanofi 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 9 inclusion and 12 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 26 Jan 2010. 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?

Yes. Results are posted in the registry (first posted 18 Jan 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 for Subjects With Locally Advanced or Metastatic (Stage IIIB or Stage IV) Non-Small Cell Lung Cancer (NSCLC) After Systemic Treatment With Gemcitabine, Docetaxel, and Bevacizumab as First Line Therapy (time frame: 1 year post-registration). 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 NCT00378573.

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 26 Jan 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in