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Non-Small Cell Lung CancerPhase 2NCT00356122

Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Docetaxel, Oxaliplatin and Bevacizumab in people with Non-Small Cell Lung Cancer, run by Sanofi 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

The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. 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, Oxaliplatin and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteUnited States
Study dates
Jul 2006to Aug 2010
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

  • Participants who met all of the following criteria during screening were considered for enrollment into the study:
  • Had the informed consent in writing for all prior to registration into the study
  • Had histologic or cytologic confirmation of locally advanced or metastatic (stage IIIb/IV) NSCLC (non-squamous histology). Participants with mixed tumor types could have been enrolled, unless small cell elements were discovered
  • Had measurable disease, defined as at least 1 lesion that could be accurately measured in at least 1 dimension (longest diameter) as ≥ 2.0 cm with conventional computerized tomography (CT) or magnetic resonance imaging (MRI) scans, or as ≥ 1.0 cm with spiral CT scan
  • Had no prior systemic chemotherapy
  • Was male or female ≥ 18 years old
Show all 18Show fewer
  • Had an estimated life expectance of ≥ 12 weeks
  • Had an ECOG performance status (PS) of 0, 1, or 2
  • Was a nonpregnant, nonlactating female Was a male or female of childbearing potential who was willing to use an effective form of contraception while on therapy and for 90 days thereafter.
  • Had adequate renal function as determined by the following within 2 weeks prior to study registration.
  • A calculated creatinine clearance greater than 45 mL/min using the Cockcroft-Gault formula
  • A urine dipstick or urinalysis for protein <2+ (Participants discovered to have ≥ 2+ proteinuria on dipstick or urinalysis at baseline had to undergo a 24 hour urine collection and had to have ≤ 1 gm of protein over 24 hours to be eligible).
  • Had a hematologic evaluation within 2 weeks prior to study registration (and met the minimum values):
  • Had absolute neutrophil count (ANC) ≥ 1,500 cells/microL
  • Had platelet count ≥ 100,000 cells/microL
  • Had hemoglobin ≥ 9.9 gm/deciL (erythropoietin [e.g., Epogen®] could have been used to maintain or exceed this level)
  • Had a partial thromboplastin time (PTT) ≤ upper limit of normal (ULN)
  • Had a hepatic function evaluation within 2 weeks prior to study registration met the eligibility criteria for bilirubin, Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase.

Who cannot join

  • Participants with any of the following were not included in the study:
  • Had received prior systemic chemotherapy or vascular endothelial growth factor (VEGF) or epidermal growth factor receptor (EGFR) inhibitor therapy at any time; or had received recent or current radiation therapy
  • Had intrathoracic lung carcinoma of squamous cell histology. (Participants with extrathoracic-only squamous cell NSCLC were eligible. Participants with only peripheral lung lesions (of any NSCLC histology) were also eligible
  • Had cardiovascular diseases and related treatment, including the following:
  • New York Heart Association Class ≥ 2 congestive heart failure; participants with a history of serious cardiac disease not adequately controlled; or a history of myocardial infarction or unstable angina pectoris within 6 months prior to study registration
  • History of stroke or transient ischemic attack within 6 months of study registration
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  • History of hypertensive crisis or hypertensive encephalopathy
  • History of thrombotic or hemorrhagic disease
  • Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
  • Clinically meaningful peripheral vascular disease, or arrhythmia
  • Inadequately controlled blood pressure (defined as systolic blood pressure >150 mm Hg and/or diastolic blood pressure >100 mm Hg)
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection) within 6 months prior to study registration
  • Therapeutic anticoagulation (Participants receiving prophylactic anticoagulation for venous access devices were allowed providing they met certain criteria)
  • Chronic daily treatment with aspirin (≥ 325 mg/day) or nonsteroidal anti-inflammatory agents known to inhibit platelet function; treatment with dipyridamole, ticlopidine, clopidogrel, or cilostazol was not allowed.
  • Had a surgical procedure in anamnesis (medical history):
  • Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to study registration, or anticipation of need for major surgical procedure during the course of the study
  • In the case of high-risk procedures, such as liver resection, thoracotomy, or neurosurgery, within 8 weeks prior to study registration
  • Minor surgical procedures (e.g., fine needle aspirations, core biopsies) within 7 days prior to registration
  • Had a serious nonhealing wound, active ulcer, or untreated bone fracture
  • Had a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study registration
  • Had a history of gross hemoptysis (defined as bright red blood of ≥ 0.5 teaspoon) within 4 weeks prior to study registration
  • Had a history of hypersensitivity reaction to drugs formulated with polysorbate 80 or platinum containing compounds
  • Had peripheral neuropathy ≥ Grade 2 (based on CTCAE v3.0)
  • Had known central nervous system (CNS) disease, except for treated brain metastasis. However, participants with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to study registration were excluded.
  • Had a history of a malignancy other than NSCLC; exceptions to this included:
  • Curatively treated basal cell carcinoma, cervical intraepithelial neoplasia, or localized prostate cancer with a current prostate-specific antigen (PSA) of less than 1.0 ng/dL on 2 successive evaluations at least 3 months apart, and the most recent evaluation being 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
  • Had symptoms of a clinically meaningful illness in the 90 days before study registration, or had history of other disease, (such as human immunodeficiency virus [HIV] positive, chronic infection [e.g., pulmonary tuberculosis], or hepatitis A, B, or C [active or previously treated]), had an active infection with fever, had metabolic dysfunction, had physical examination finding, or had clinical a laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug, that might affect the interpretation of the results of the study, or render the participant at high risk from treatment complications; (testing for these conditions was at investigator discretion)
  • Had a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
  • The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sanofi-Aventis Administrative Office

    Bridgewater, New Jersey, 08807

Other trials in United States

About this study

Official title: A Phase II Multicenter Study of Docetaxel and Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Chemotherapy-Naïve Subjects With Unresectable Locally Advanced and/or Recurrent (Stage IIIB) or Metastatic (Stage IV) Non-Squamous Cell Histology Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor and may also prevent tumor growth. The three investigational drugs are United States Food and Drug Administration (FDA) approved.

Read the detailed description

The planned treatment duration for each participant is six 21-day treatment cycles of combination therapy; non-progressing participants will continue on bevacizumab monotherapy until progression. After discontinuation or after completion of all study treatments, all participants will be contacted every 3 months for a maximum of 2 years from first treatment to document overall survival and record new anticancer treatment (chemotherapy or biologic).

Keywords
Lung, non-small cell, chemotherapy, tumor, advanced, recurrent, metastatic, Non-Small Cell Lung Cancer (NSCLC)
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms, Recurrence, Neoplasm Metastasis

What participants receive

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

  • DocetaxelDrug

    70 mg/m^2 administered intravenously (IV) on Day 1 for Cycles 1-6 (the treatment cycle is 3 weeks)

  • OxaliplatinDrug

    100 mg/m^2 administered IV on Day 1 for Cycles 1-6

  • BevacizumabDrug

    15 mg/kg administered IV on Day 1 for Cycles 1-6, and every 3 weeks during maintenance therapy for a total treatment of one year, until disease progression or death due to any cause, whichever occurs first.

Study groups in NCT00356122
Study groupRoleWhat they receive
Docetaxel/Oxaliplatin/BevacizumabExperimentalParticipants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of docetaxel, followed by oxaliplatin, and then bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
Receives: Drug: Docetaxel; Drug: Oxaliplatin; Drug: Bevacizumab

What is being measured

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

  1. Progression-free Survival (PFS)

    PFS was defined as the interval from the date of registration to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurred first.

    Progressive disease occurred when the participant had at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.

    Measured: Baseline to PFS (up to 24 months after the first treatment)

Secondary outcomes (4)

  1. Objective Response Rate

    Objective response rate is the percentage of participants with an objective response. Improvements in tumor measurements from baseline values were assigned a status of Complete Response (CR) or Partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST). Overall objective response was the sum of CR and PR.

    CR referred to the disappearance of all target lesions, and PR was at least 30% decrease in the sum of the longest diameter (LD) of target lesions, compared to the baseline sum LD. Responses were confirmed by repeat assessments within 4 to 6 weeks.

    Measured: Baseline to CR or PR (up to 24 months after the first treatment)

  2. Time-to-treatment Failure (TTF)

    Treatment failure was defined as an event which lead to the participant's withdrawal from the study treatment due to lack of efficacy, disease progression, adverse events, or due to a participant's request as recorded in the Case Report Form (CRF), death, or use of other anticancer therapy.

    TTF was assessed using Kaplan-Meier method, and the median TTF with 95% CIs was computed using the Brookmeyer and Crowley method.

    Measured: Baseline to treatment failure (up to 24 months after the first treatment)

  3. Overall Survival (OS)

    OS was measured from the date of registration to the date of death due to any cause, or to the date of last contact (for censored observations). OS was assessed by the Kaplan-Meier method and the estimates of median survival time with 95% CI are reported.

    Measured: Baseline to OS (up to 24 months after the first treatment)

  4. Number of Participants With Treatment-related Toxicities

    Treatment-related toxicities were serious and non-serious adverse events (AE) considered related to study treatment by the investigator.

    AEs were any unfavorable and unintended signs, symptoms, syndromes, or illnesses that developed or worsened during the observation period, and included abnormal results from diagnostic procedures. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, appeared as a congenital anomaly or were considered medically important by the investigator.

    Measured: From baseline up to 30 days after treatment discontinuation

Timeline

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

  1. First posted25 Jul 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionAug 2010
  4. Study completionAug 2010

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
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00356122
Sponsor's protocol ID
DOCOX_L_00716
Status last verified
Aug 2011
First submitted
24 Jul 2006
Last updated
17 Oct 2011

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Oxaliplatin 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 18 inclusion and 30 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 17 Oct 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?

Yes. Results are posted in the registry (first posted 16 Sep 2011). 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: Baseline to PFS (up to 24 months after the first treatment)). 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 NCT00356122.

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 17 Oct 2011.

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