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
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.
OBJECTIVES:
Primary
Secondary
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.
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 →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.
DISEASE CHARACTERISTICS:
Histologically confirmed non-squamous cell non-small cell lung cancer
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
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Treatment repeats every 21 days for up to 6 courses.
Biological: bevacizumab · Drug: docetaxel · Drug: gemcitabine hydrochloride
15 mg/kg on day 1 of a 21-day cycle
75 mg/m2 on day 1
900 mg/m2 on days 1, and 8,
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
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
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
Patients were recruited from local medical clinics from 12/2009 to 4/2011
| Milestone | Bevacizumab, Docetaxel, and Gemcitabine |
|---|---|
| Started | 13 |
| Completed | 3 |
| Not completed | 10 |
| Withdrew: Lack of efficacy | 5 |
| Withdrew: Adverse event | 4 |
| Withdrew: Withdrawal by subject | 1 |
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.
| months | Bevacizumab, Docetaxel, and Gemcitabine |
|---|---|
| Progression Free Survival(PFS) | 5.6 (3.9 to 7.4) |
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.
| months | Bevacizumab, Docetaxel, and Gemcitabine |
|---|---|
| Median Time to Progression | 5.6 (3.9 to 7.4) |
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)
| participants | Bevacizumab, Docetaxel, and Gemcitabine |
|---|---|
| Stable Disease | 2 |
| Partial Response | 9 |
| Progressive Disease | 1 |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bevacizumab, Docetaxel, and Gemcitabine | — | 10/13 (76.9%) | 13/13 (100%) |
| Event | Bevacizumab, Docetaxel, and Gemcitabine |
|---|---|
| Lung InfectionRespiratory, thoracic and mediastinal disorders | 7/13 |
| Thromboembolic eventVascular disorders | 3/13 |
| NeutropeniaBlood and lymphatic system disorders | 2/13 |
| Atrial fibrillationCardiac disorders | 2/13 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 2/13 |
| AnemiaBlood and lymphatic system disorders | 1/13 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/13 |
| Depressed Level of ConsciousnessNervous system disorders | 1/13 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 1/13 |
| Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders | 1/13 |
| Event | Bevacizumab, Docetaxel, and Gemcitabine |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 13/13 |
| LeukocytopeniaBlood and lymphatic system disorders | 12/13 |
| HyperglycemiaMetabolism and nutrition disorders | 12/13 |
| HemoglobinemiaBlood and lymphatic system disorders | 10/13 |
| LymphopeniaBlood and lymphatic system disorders | 10/13 |
| FatigueGeneral disorders | 10/13 |
| AnorexiaGastrointestinal disorders | 10/13 |
| Mucositis/stomatitis-oralGastrointestinal disorders | 10/13 |
| NauseaGastrointestinal disorders | 9/13 |
| Pain- Muscular/skeletalMusculoskeletal and connective tissue disorders | 9/13 |
| Age, Continuous(years) | Bevacizumab, Docetaxel, and Gemcitabine |
|---|---|
| Median | 63 (35 to 69) |
| Sex: Female, Male(Participants) | Bevacizumab, Docetaxel, and Gemcitabine |
|---|---|
| Female | 2 |
| Male | 11 |
| Ethnicity (NIH/OMB)(Participants) | Bevacizumab, Docetaxel, and Gemcitabine |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Bevacizumab, Docetaxel, and Gemcitabine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 13 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Bevacizumab, Docetaxel, and Gemcitabine |
|---|---|
| United States | 13 |
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.
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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
Nathan Pennell, MD, PhD