Trial Outcomes & Findings for Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer (NCT NCT00362882)

Last Updated: 2017-12-05

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

81 participants

Primary outcome timeframe

Up to 4 years

Results posted on

2017-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study	Arm 2 Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study
Overall Study STARTED	40	41
Overall Study COMPLETED	40	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=40 Participants Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study	Arm 2 n=41 Participants Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study	Total n=81 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	61 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Caucasion	32 participants n=5 Participants	33 participants n=7 Participants	65 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants
Race/Ethnicity, Customized African Americian	5 participants n=5 Participants	1 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	41 participants n=7 Participants	81 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Outcome measures

Outcome measures
Measure	Arm 1 n=40 Participants Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study	Arm 2 n=41 Participants Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study
Overall Response Rate	10 percentage of participants	10 percentage of participants

SECONDARY outcome

Timeframe: From first day of treatment to time of death due to any cause, up to 4 years

Will be estimated using the product-limit method of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Arm 1 n=40 Participants Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study	Arm 2 n=41 Participants Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study
Overall Survival	13.3 Months Interval 7.0 to 17.0	7.8 Months Interval 6.0 to 18.0

SECONDARY outcome

Timeframe: Up to 4 years

Disease control rate was defined as the rate of partial response (PR) plus stable disease (SD; for at least 2 cycles).

Outcome measures

Outcome measures
Measure	Arm 1 n=40 Participants Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study	Arm 2 n=41 Participants Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study
Disease Control Rate	50 percentage of participants	49 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Arm 1 n=40 Participants Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study	Arm 2 n=41 Participants Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study
Progression-free Survival @ 6 Months	30 percent of participants	17 percent of participants

Adverse Events

Arm 1

Serious events: 15 serious events

Other events: 40 other events

Deaths: 0 deaths

Arm 2

Serious events: 21 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

DCC Project Administrator

California Cancer Consortium

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Arm 1 n=40 participants at risk Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study	Arm 2 n=41 participants at risk Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study
Blood and lymphatic system disorders Hemoglobin decreased	7.5% 3/40 • Number of events 5 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Left ventricular dysfunction	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Pericarditis	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 2 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Fecal incontinence	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Small intestinal stenosis	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 2 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Death	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Disease progression	5.0% 2/40 • Number of events 2 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.8% 4/41 • Number of events 4 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Pneumonia	10.0% 4/40 • Number of events 5 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Activated partial thromboplastin time prolonged	2.5% 1/40 • Number of events 2 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukocyte count decreased	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	5.0% 2/40 • Number of events 2 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 3 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	12.5% 5/40 • Number of events 5 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.1% 7/41 • Number of events 7 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood uric acid increased	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 3 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium decreased	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum sodium decreased	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Hydrocephalus	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Seizure	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Syncope	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Renal failure	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events
Measure	Arm 1 n=40 participants at risk Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study	Arm 2 n=41 participants at risk Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8. docetaxel: Given IV bortezomib: Given IV laboratory biomarker analysis: correlative study immunoenzyme technique: correlative study immunohistochemistry staining method: correlative study pharmacological study: correlative study
Blood and lymphatic system disorders Blood disorder	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Hemoglobin decreased	72.5% 29/40 • Number of events 94 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	68.3% 28/41 • Number of events 83 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Conduction disorder	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Left ventricular failure	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Palpitations	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	10.0% 4/40 • Number of events 5 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.8% 4/41 • Number of events 9 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Tinnitus	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 8 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Dry eye syndrome	2.5% 1/40 • Number of events 3 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eye disorder	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 3 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Vision blurred	5.0% 2/40 • Number of events 3 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 2 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Vitreous hemorrhage	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Watering eyes	12.5% 5/40 • Number of events 14 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 5 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal distension	7.5% 3/40 • Number of events 4 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.8% 4/41 • Number of events 4 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	12.5% 5/40 • Number of events 8 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	29.3% 12/41 • Number of events 16 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Anal hemorrhage	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Colitis	5.0% 2/40 • Number of events 3 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	30.0% 12/40 • Number of events 21 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.5% 17/41 • Number of events 23 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	32.5% 13/40 • Number of events 17 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.7% 13/41 • Number of events 15 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	7.5% 3/40 • Number of events 9 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 3 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	5.0% 2/40 • Number of events 3 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Ear, nose and throat examination abnormal	7.5% 3/40 • Number of events 4 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.2% 5/41 • Number of events 7 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophagitis	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Flatulence	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastritis	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 4 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 3 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Hemorrhoids	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	12.5% 5/40 • Number of events 5 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	45.0% 18/40 • Number of events 31 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	46.3% 19/41 • Number of events 31 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Stomach pain	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Toothache	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	20.0% 8/40 • Number of events 12 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.6% 15/41 • Number of events 22 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chest pain	7.5% 3/40 • Number of events 3 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 4 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	5.0% 2/40 • Number of events 3 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 3 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Disease progression	60.0% 24/40 • Number of events 24 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	58.5% 24/41 • Number of events 24 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	20.0% 8/40 • Number of events 18 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.0% 9/41 • Number of events 12 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Facial pain	0.00% 0/40 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	75.0% 30/40 • Number of events 100 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	70.7% 29/41 • Number of events 81 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	10.0% 4/40 • Number of events 5 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.2% 5/41 • Number of events 8 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Gait abnormal	2.5% 1/40 • Number of events 1 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events reported over a period of 4 years, 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.