ClinicalTrials.gg
CompletedNCT00970684Updated Aug 16, 2022Results posted

Bevacizumab, Docetaxel, and Gemcitabine Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

A Phase 2 interventional study of bevacizumab and docetaxel in Lung Cancer, sponsored by Nathan Pennell, MD, PhD. Completed at 4 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2022-08-16.

Sponsored by Nathan Pennell, MD, PhD · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years to 120 Years
Sex
All
01

Study summary

RATIONALE: 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. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Estimate the 1-year progression-free survival rate in patients with stage IIIB, stage IV, or recurrent non-squamous cell non-small cell lung cancer treated with bevacizumab, docetaxel, and gemcitabine hydrochloride.

Secondary

  • Evaluate the median time to progression in patients treated with this regimen.
  • Estimate the response rate in patients treated with this regimen.
  • Determine the median overall survival of patients treated with this regimen.
  • Determine the incidence of adverse events associated with this regimen in these patients.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes and docetaxel IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease may then continue to receive bevacizumab alone for up to 12 months in the absence of disease progression.

After completion of study treatment, patients are followed up every 3 months.

02

Conditions studied

  • Lung Cancer

Keywords

  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
03

In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's enrollment of 13 is below the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Nathan Pennell, MD, PhD is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-squamous cell non-small cell lung cancer

    • Stage IIIB (with pleural effusion), stage IV, or recurrent disease
  • Bidimensionally measurable disease
  • No known CNS disease, except for previously treated brain metastasis defined as no evidence of progression or hemorrhage after treatment AND no ongoing requirement for dexamethasone as documented by clinical examination, MRI, or CT scan

    • Treatment for brain metastases may have included whole brain radiotherapy, radiosurgery (gamma knife, LINAC, or equivalent), or a combination of therapy as deemed appropriate by the treating physician
    • Stable dose of anticonvulsants allowed
  • No known metastatic disease to the gastrointestinal tract (e.g., stomach, small bowel, or large bowel)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9 g/dL
  • Bilirubin ≤ 2.0 mg/dL
  • AST or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if hepatic metastases are present)
  • Serum creatinine ≤ 1.8 mg/dL
  • Urine protein:creatinine ratio \< 1.0 OR proteinuria \< 2+ by urine dipstick OR ≤ 1 g of protein by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Available for regular follow-ups
  • No inadequately controlled hypertension, defined as systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg despite antihypertensive medications
  • No history of hypertensive crisis or hypertensive encephalopathy
  • No NYHA class II-IV congestive heart failure
  • No myocardial infarction or unstable angina within the past 6 months
  • No stroke or transient ischemic attack within the past 6 months
  • No significant vascular disease (e.g., aortic aneurysm, aortic dissection requiring surgical repair, or recent peripheral arterial thrombosis) within the past 6 months
  • No symptomatic peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
  • No history of colonic diverticular disease (i.e., diverticulosis or diverticulitis)
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No serious, nonhealing wound, ulcer, or bone fracture
  • No known hypersensitivity to any component of bevacizumab
  • No hemoptysis (bright red blood of ≥ ½ teaspoon per episode) within the past 3 months
  • No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy or biological therapy
  • No prior radiotherapy to an area of measurable disease unless there is documented progressive disease after completion of therapy
  • More than 2 weeks since prior radiotherapy
  • More than 4 weeks since prior and no concurrent participation in another experimental drug study, except for a Genentech-sponsored bevacizumab cancer study
  • More than 28 days since prior major surgical procedure or open biopsy
  • More than 3 months since prior abdominal surgery
  • More than 3 months since prior neurosurgical resection or brain biopsy
  • More than 7 days since prior core biopsy or other minor surgical procedure, except placement of a vascular access device
  • No concurrent major surgical procedure
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Bevacizumab, Docetaxel, and Gemcitabine

    Treatment repeats every 21 days for up to 6 courses.

    Biological: bevacizumab · Drug: docetaxel · Drug: gemcitabine hydrochloride

Interventions

06

What researchers measure

Primary outcomes

  1. Progression Free Survival(PFS)

    PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression.

    Time frame: 1 year

Secondary outcomes

  1. Median Time to Progression

    Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm.

    Time frame: 1 year

  2. Best Response

    The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease)

    Time frame: 1 year

07

Results

Posted Feb 4, 2014

Participant flow

Patients were recruited from local medical clinics from 12/2009 to 4/2011

Participant flow — Overall Study
MilestoneBevacizumab, Docetaxel, and Gemcitabine
Started13
Completed3
Not completed10
Withdrew: Lack of efficacy5
Withdrew: Adverse event4
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryProgression Free Survival(PFS)

PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression.

Time frame:
1 year
Reported as:
Median · months
Progression Free Survival(PFS)
monthsBevacizumab, Docetaxel, and Gemcitabine
Progression Free Survival(PFS)5.6 (3.9 to 7.4)
SecondaryMedian Time to Progression

Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm.

Time frame:
1 year
Reported as:
Median · months
Median Time to Progression
monthsBevacizumab, Docetaxel, and Gemcitabine
Median Time to Progression5.6 (3.9 to 7.4)
SecondaryBest Response

The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease)

Time frame:
1 year
Reported as:
Number · participants
Best Response
participantsBevacizumab, Docetaxel, and Gemcitabine
Stable Disease2
Partial Response9
Progressive Disease1

Adverse events

Collected over Patients are followed for adverse events while on study for up to 2 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bevacizumab, Docetaxel, and Gemcitabine—10/13 (76.9%)13/13 (100%)
Most frequent serious events
Most frequent serious events
EventBevacizumab, Docetaxel, and Gemcitabine
Lung InfectionRespiratory, thoracic and mediastinal disorders7/13
Thromboembolic eventVascular disorders3/13
NeutropeniaBlood and lymphatic system disorders2/13
Atrial fibrillationCardiac disorders2/13
PneumonitisRespiratory, thoracic and mediastinal disorders2/13
AnemiaBlood and lymphatic system disorders1/13
ThrombocytopeniaBlood and lymphatic system disorders1/13
Depressed Level of ConsciousnessNervous system disorders1/13
Pleural EffusionRespiratory, thoracic and mediastinal disorders1/13
Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders1/13
Most frequent other events
Showing 10 of 92
Most frequent other events
EventBevacizumab, Docetaxel, and Gemcitabine
NeutropeniaBlood and lymphatic system disorders13/13
LeukocytopeniaBlood and lymphatic system disorders12/13
HyperglycemiaMetabolism and nutrition disorders12/13
HemoglobinemiaBlood and lymphatic system disorders10/13
LymphopeniaBlood and lymphatic system disorders10/13
FatigueGeneral disorders10/13
AnorexiaGastrointestinal disorders10/13
Mucositis/stomatitis-oralGastrointestinal disorders10/13
NauseaGastrointestinal disorders9/13
Pain- Muscular/skeletalMusculoskeletal and connective tissue disorders9/13

Baseline characteristics

Age, Continuous
Age, Continuous(years)Bevacizumab, Docetaxel, and Gemcitabine
Median63 (35 to 69)
Sex: Female, Male
Sex: Female, Male(Participants)Bevacizumab, Docetaxel, and Gemcitabine
Female2
Male11
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Bevacizumab, Docetaxel, and Gemcitabine
Hispanic or Latino1
Not Hispanic or Latino12
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Bevacizumab, Docetaxel, and Gemcitabine
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White13
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Bevacizumab, Docetaxel, and Gemcitabine
United States13
08

Study locations

4 sites
  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
    Cleveland, Ohio 44106, United States
  • Fairview Hospital, Moll Pavilion
    Cleveland, Ohio 44111, United States
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
    Cleveland, Ohio 44195, United States
  • Hillcrest Hospital, a Cleveland Clinic Hospital
    Mayfield Heights, Ohio 44124, United States
09

References and documents

Publications

  • Patil PD, Shapiro M, Hashemi Sadraei N, Pennell NA. An Open-Label Phase II Trial of Bevacizumab plus Docetaxel and Gemcitabine in Advanced, Previously Untreated Nonsquamous Non-Small Cell Lung Cancer. Oncologist. 2019 Apr;24(4):457-e126. doi: 10.1634/theoncologist.2018-0857. Epub 2019 Jan 2. PubMed 30602615 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2009, a primary completion of Sep 2011 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.

Results were first posted in Feb 2014, 2 years 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2009
First posted
Sep 2, 2009
Start
Sep 2009
Primary completionActual
Sep 2011
CompletionActual
Sep 2011
Results first posted
Feb 4, 2014
Last update
Aug 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00970684
Lead sponsor
Nathan Pennell, MD, PhD
Responsible party
Nathan Pennell, MD, PhD (Principal Investigator, Case Comprehensive Cancer Center) — Sponsor-investigator
First posted
Sep 2, 2009
Start date
Sep 2009
Primary completion
Sep 2011
Completion
Sep 2011
Results posted
Feb 4, 2014
Last update
Aug 16, 2022

Study contacts

Nathan Pennell, MD, PhD
principal investigator · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Afshin Dowlati, MD
principal investigator · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Bevacizumab · Docetaxel · Gemcitabine

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