Trial Outcomes & Findings for Bevacizumab, Docetaxel, and Gemcitabine Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NCT NCT00970684)

Last Updated: 2022-08-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

1 year

Results posted on

2022-08-16

Participant Flow

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

Participant milestones

Participant milestones
Measure	Bevacizumab, Docetaxel, and Gemcitabine Treatment repeats every 21 days for up to 6 courses.
Overall Study STARTED	13
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Bevacizumab, Docetaxel, and Gemcitabine Treatment repeats every 21 days for up to 6 courses.
Overall Study Lack of Efficacy	5
Overall Study Adverse Event	4
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab, Docetaxel, and Gemcitabine n=13 Participants Treatment repeats every 21 days for up to 6 courses.
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Intent to treat

Outcome measures

Outcome measures
Measure	Bevacizumab, Docetaxel, and Gemcitabine n=13 Participants Treatment repeats every 21 days for up to 6 courses.
Progression Free Survival(PFS)	5.6 months Interval 3.9 to 7.4

SECONDARY outcome

Timeframe: 1 year

Population: Intent to treat

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.

Outcome measures

Outcome measures
Measure	Bevacizumab, Docetaxel, and Gemcitabine n=13 Participants Treatment repeats every 21 days for up to 6 courses.
Median Time to Progression	5.6 months Interval 3.9 to 7.4

SECONDARY outcome

Timeframe: 1 year

Population: One patient was unevaluable for response due to missing baseline tumor measurement.

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)

Outcome measures

Outcome measures
Measure	Bevacizumab, Docetaxel, and Gemcitabine n=12 Participants Treatment repeats every 21 days for up to 6 courses.
Best Response Stable Disease	2 participants
Best Response Partial Response	9 participants
Best Response Progressive Disease	1 participants

Adverse Events

Bevacizumab, Docetaxel, and Gemcitabine

Serious events: 10 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bevacizumab, Docetaxel, and Gemcitabine n=13 participants at risk Treatment repeats every 21 days for up to 6 courses.
Blood and lymphatic system disorders Anemia	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Vascular disorders Thromboembolic event	23.1% 3/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Lung Infection	53.8% 7/13 • Patients are followed for adverse events while on study for up to 2 years.
Blood and lymphatic system disorders Neutropenia	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.
Blood and lymphatic system disorders Thrombocytopenia	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Nervous system disorders Depressed Level of Consciousness	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Cardiac disorders Atrial fibrillation	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.

Other adverse events

Other adverse events
Measure	Bevacizumab, Docetaxel, and Gemcitabine n=13 participants at risk Treatment repeats every 21 days for up to 6 courses.
Immune system disorders Allergic reaction/hypersensitivity	38.5% 5/13 • Patients are followed for adverse events while on study for up to 2 years.
Ear and labyrinth disorders Tinnitus	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.
Blood and lymphatic system disorders Anemia	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Blood and lymphatic system disorders Hemoglobinemia	76.9% 10/13 • Patients are followed for adverse events while on study for up to 2 years.
Blood and lymphatic system disorders Leukocytopenia	92.3% 12/13 • Patients are followed for adverse events while on study for up to 2 years.
Blood and lymphatic system disorders Lymphopenia	76.9% 10/13 • Patients are followed for adverse events while on study for up to 2 years.
Blood and lymphatic system disorders Neutropenia	100.0% 13/13 • Patients are followed for adverse events while on study for up to 2 years.
Blood and lymphatic system disorders Thrombocytopenia	61.5% 8/13 • Patients are followed for adverse events while on study for up to 2 years.
Cardiac disorders Superaventricular and nodal arrhythmia-Atrial fibrillation	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.
Cardiac disorders Supraventricular and nodal arrythmia-Sinus tachycardia	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Cardiac disorders Hypertension	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.
Cardiac disorders Hypotension	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
General disorders Fatigue	76.9% 10/13 • Patients are followed for adverse events while on study for up to 2 years.
General disorders Fever	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.
General disorders Insomnia	38.5% 5/13 • Patients are followed for adverse events while on study for up to 2 years.
General disorders Rigors/chills	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
General disorders Sweating	23.1% 3/13 • Patients are followed for adverse events while on study for up to 2 years.
General disorders Weight gain	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
General disorders Weight loss	46.2% 6/13 • Patients are followed for adverse events while on study for up to 2 years.
Skin and subcutaneous tissue disorders Bruising	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Skin and subcutaneous tissue disorders Dry skin	46.2% 6/13 • Patients are followed for adverse events while on study for up to 2 years.
Skin and subcutaneous tissue disorders Flushing	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Skin and subcutaneous tissue disorders Alopecia	53.8% 7/13 • Patients are followed for adverse events while on study for up to 2 years.
Skin and subcutaneous tissue disorders Nail changes	30.8% 4/13 • Patients are followed for adverse events while on study for up to 2 years.
Skin and subcutaneous tissue disorders Rash- acne/acneiform	38.5% 5/13 • Patients are followed for adverse events while on study for up to 2 years.
Skin and subcutaneous tissue disorders Ulceration	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.
Endocrine disorders Night Sweats, intermittent	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Anorexia	76.9% 10/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Colitis	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Constipation	61.5% 8/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Dehydration	23.1% 3/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Diarrhea	61.5% 8/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Heartburn/dyspepsia	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Hemorrhoids	23.1% 3/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Mucositis/stomatitis-oral	76.9% 10/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Mucositis/stomatitis-rectum	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Nausea	69.2% 9/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Dysgeusia	61.5% 8/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Vomiting	46.2% 6/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Hemorrhage, GI	30.8% 4/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Hemorrhage-pulmonary/upper respiratory	53.8% 7/13 • Patients are followed for adverse events while on study for up to 2 years.
Blood and lymphatic system disorders Hemorrhage/Bleeding	23.1% 3/13 • Patients are followed for adverse events while on study for up to 2 years.
Infections and infestations Infection-Lung	30.8% 4/13 • Patients are followed for adverse events while on study for up to 2 years.
Infections and infestations Infection	46.2% 6/13 • Patients are followed for adverse events while on study for up to 2 years.
Infections and infestations Infection-Bladder	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Infections and infestations Infection-Conjuctiva	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Infections and infestations Infection-Mucosa	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.
Infections and infestations Infection-Upper aerodigestive NOS	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Infections and infestations Opportunistic infection	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Blood and lymphatic system disorders Edema-limb	23.1% 3/13 • Patients are followed for adverse events while on study for up to 2 years.
Blood and lymphatic system disorders Lymphocele	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Metabolism and nutrition disorders ALT, SGPT	30.8% 4/13 • Patients are followed for adverse events while on study for up to 2 years.
Metabolism and nutrition disorders AST, SGOT	38.5% 5/13 • Patients are followed for adverse events while on study for up to 2 years.
Metabolism and nutrition disorders Hypoalbuminemia	30.8% 4/13 • Patients are followed for adverse events while on study for up to 2 years.
Metabolism and nutrition disorders Alkaline phosphatase	23.1% 3/13 • Patients are followed for adverse events while on study for up to 2 years.
Metabolism and nutrition disorders Hypocalcemia	23.1% 3/13 • Patients are followed for adverse events while on study for up to 2 years.
Metabolism and nutrition disorders Hyperglycemia	92.3% 12/13 • Patients are followed for adverse events while on study for up to 2 years.
Metabolism and nutrition disorders Hypoglycemia	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Metabolism and nutrition disorders Hypomagnesemia	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Metabolism and nutrition disorders Glycosuria	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Metabolism and nutrition disorders Hypophosphatemia	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Metabolism and nutrition disorders Hyperkalemia	38.5% 5/13 • Patients are followed for adverse events while on study for up to 2 years.
Metabolism and nutrition disorders Proteinuria	53.8% 7/13 • Patients are followed for adverse events while on study for up to 2 years.
Metabolism and nutrition disorders Hyponatremia	53.8% 7/13 • Patients are followed for adverse events while on study for up to 2 years.
Musculoskeletal and connective tissue disorders Arthritis	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Musculoskeletal and connective tissue disorders Fracture	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Nervous system disorders Confusion	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.
Nervous system disorders Dizziness	30.8% 4/13 • Patients are followed for adverse events while on study for up to 2 years.
Nervous system disorders Extrapyramidal/involuntary movement/restlessness	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.
Nervous system disorders Mood alterations	46.2% 6/13 • Patients are followed for adverse events while on study for up to 2 years.
Nervous system disorders Neuropathy	61.5% 8/13 • Patients are followed for adverse events while on study for up to 2 years.
Nervous system disorders Somnolence	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Eye disorders Dry eye syndrome	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Eye disorders Epiphora	38.5% 5/13 • Patients are followed for adverse events while on study for up to 2 years.
Gastrointestinal disorders Pain- Abdomen NOS	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Pain- Chest/thorax	23.1% 3/13 • Patients are followed for adverse events while on study for up to 2 years.
General disorders Pain- dental/teeth/peridontal	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Eye disorders Pain- eye	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Nervous system disorders Pain- Head/headache	46.2% 6/13 • Patients are followed for adverse events while on study for up to 2 years.
Musculoskeletal and connective tissue disorders Pain- Muscular/skeletal	69.2% 9/13 • Patients are followed for adverse events while on study for up to 2 years.
General disorders Pain-other	30.8% 4/13 • Patients are followed for adverse events while on study for up to 2 years.
General disorders Pain- Throat/pharynx/larynx	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Cough	38.5% 5/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	46.2% 6/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	30.8% 4/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Pneumonititis/pulmonary infiltrates	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Bronchospasm, wheezing	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	23.1% 3/13 • Patients are followed for adverse events while on study for up to 2 years.
Reproductive system and breast disorders Sexual/reproductive function	7.7% 1/13 • Patients are followed for adverse events while on study for up to 2 years.
Vascular disorders Thrombosis	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.
Respiratory, thoracic and mediastinal disorders Hiccups	15.4% 2/13 • Patients are followed for adverse events while on study for up to 2 years.

Additional Information

Nathan Pennell MD

Case Comprehensive Cancer Center

Phone: 216-445-9285

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place