Trial Outcomes & Findings for Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer (NCT NCT00238420)

Last Updated: 2022-07-19

Results Overview

In each group, the number of patients was tabulated by type and grade (gr) of treatment-related toxicity (CTCAE v3.0). Only the following types of toxicity within 90 days of treatment start were considered: ≥ gr4 neutropenia, ≥ gr4 febrile neutropenia, ≥ gr3 diarrhea, ≥ gr3 nausea/vomiting, ≥ gr3 thrombocytopenia, ≥ gr3 renal, pulmonary, hepatic, or neurologic toxicity, ≥ gr3 rectal or genitourinary bleeding, ≥ gr3 left ventricular failure, or ≥ gr2 other cardiac toxicity. The study was designed to estimate the rate of acute treatment-related toxicity separately in each group of patients. Using the Fleming's one-sample multiple test procedure with Type I and II errors each set at 10%, 40 cases/group were required to reject the null hypothesis that the true toxicity rate is greater than 25% in favor of the alternative hypothesis that the true rate is no more than 10%. Six or more patients with the designated toxicities out of 40 would result in rejecting the null hypothesis.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

70 participants

Primary outcome timeframe

From start of protocol treatment to 90 days

Results posted on

2022-07-19

Participant Flow

After patient registration, sites submitted tissue to central her2/neu evaluation. If tissue was evaluable and a patient continued on study, then treatment arm was assigned. Seventy-six patients were registered and 6 did not continue to treatment assignment: 2 patient withdrawal, 2 protocol violation, 1 progressive disease, 1 institutional error.

Participant milestones

Participant milestones
Measure	HER2+ :RT, Paclitaxel, and Trastuzumab Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy	HER2- :RT and Paclitaxel Paclitaxel chemotherapy concurrent with radiation therapy
Overall Study STARTED	22	48
Overall Study COMPLETED	21	47
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	HER2+ :RT, Paclitaxel, and Trastuzumab Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy	HER2- :RT and Paclitaxel Paclitaxel chemotherapy concurrent with radiation therapy
Overall Study Protocol Violation	1	1

Baseline Characteristics

Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HER2+ :RT, Paclitaxel, and Trastuzumab n=21 Participants Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy	HER2- :RT and Paclitaxel n=47 Participants Paclitaxel chemotherapy concurrent with radiation therapy	Total n=68 Participants Total of all reporting groups
Age, Continuous	80 years n=5 Participants	73 years n=7 Participants	75 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	36 Participants n=7 Participants	55 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of protocol treatment to 90 days

Population: All eligible patients who started study treatment

Outcome measures

Outcome measures
Measure	HER2+ :RT, Paclitaxel, and Trastuzumab n=21 Participants Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy	HER2- :RT and Paclitaxel n=47 Participants Paclitaxel chemotherapy concurrent with radiation therapy
Acute Treatment-related Toxicity	7 participants	14 participants

SECONDARY outcome

Timeframe: From registration to end of treatment; up to 64 days."

Population: All eligible patients who started study treatment

The number of patients within each group who completed all elements of protocol treatment are reported.

Outcome measures

Outcome measures
Measure	HER2+ :RT, Paclitaxel, and Trastuzumab n=21 Participants Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy	HER2- :RT and Paclitaxel n=47 Participants Paclitaxel chemotherapy concurrent with radiation therapy
Treatment Completion	13 participants	34 participants

SECONDARY outcome

Timeframe: At 12 weeks from treatment start

Population: All eligible patients who started treatment and had an evaluation to assess response by 12 weeks

The number of patients within each group who achieved a complete response to protocol treatment by 12 weeks are reported. Complete response is defined as no gross tumor at cystoscopy or negative biopsies or both by week 12 after completion of protocol treatment.

Outcome measures

Outcome measures
Measure	HER2+ :RT, Paclitaxel, and Trastuzumab n=13 Participants Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy	HER2- :RT and Paclitaxel n=33 Participants Paclitaxel chemotherapy concurrent with radiation therapy
Complete Response to Treatment	61.5 percentage of participants Interval 31.6 to 86.1	57.6 percentage of participants Interval 39.2 to 74.5

SECONDARY outcome

Timeframe: From start of treatment to last follow-up. Maximum follow-up at time of analysis was 9.9 years.

Population: Eligible participants who started treatment. (This population changed since the initial analysis: 3 participants first thought to be eligible were later determined to be ineligible.)

Disease (failure) is defined as any bladder cancer progression determined by all measures of disease including physical exam, imaging, and biopsies. Disease-free survival time is defined as time from treatment start to the date of first progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all patients had been on study for at least 5 years. This is a non-randomized phase I/II trial in which the two patient groups are not compared.

Outcome measures

Outcome measures
Measure	HER2+ :RT, Paclitaxel, and Trastuzumab n=20 Participants Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy	HER2- :RT and Paclitaxel n=45 Participants Paclitaxel chemotherapy concurrent with radiation therapy
Progression-free Survival	1.1 years Interval 0.6 to 2.8	0.8 years Interval 0.4 to 3.0

SECONDARY outcome

Timeframe: From the date of treatment started to death, assessed up to at least 5 years

Population: Eligible participants who started treatment. (This population changed since the initial analysis: 3 participants first thought to be eligible were later determined to be ineligible.)

Overall survival time is defined as time from treatment start to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all patients had been on study for at least 5 years. This is a non-randomized phase I/II trial in which the two patient groups are not compared.

Outcome measures

Outcome measures
Measure	HER2+ :RT, Paclitaxel, and Trastuzumab n=20 Participants Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy	HER2- :RT and Paclitaxel n=45 Participants Paclitaxel chemotherapy concurrent with radiation therapy
Overall Survival	2.8 years Interval 1.1 to 4.4	2.0 years Interval 1.1 to 8.5

Adverse Events

HER2+ :RT, Paclitaxel, and Trastuzumab

Serious events: 6 serious events

Other events: 20 other events

Deaths: 0 deaths

HER2- :RT and Paclitaxel

Serious events: 15 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	HER2+ :RT, Paclitaxel, and Trastuzumab n=21 participants at risk Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy	HER2- :RT and Paclitaxel n=47 participants at risk Paclitaxel chemotherapy concurrent with radiation therapy
Blood and lymphatic system disorders Hemoglobin	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Cardiac disorders Myocardial ischemia	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Cardiac disorders Sinus bradycardia	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Cardiac disorders Supraventricular arrhythmia NOS	4.8% 1/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Abdominal pain NOS	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Colonic perforation	4.8% 1/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Diarrhea NOS	19.0% 4/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	6.4% 3/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Enteritis	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Proctitis NOS	4.8% 1/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Vomiting NOS	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
General disorders Edema: limb	4.8% 1/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
General disorders Pyrexia	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	4.3% 2/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
General disorders Sudden death	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Hepatobiliary disorders Hepatobiliary/pancreas - Other	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Urinary tract NOS	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Infections and infestations Kidney infection NOS	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Infections and infestations Pneumonia NOS	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Infections and infestations Urinary tract infection NOS	4.8% 1/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	4.3% 2/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Injury, poisoning and procedural complications Vascular access NOS complication	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	4.3% 2/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Investigations Leukopenia NOS	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Investigations Lymphopenia	4.8% 1/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Metabolism and nutrition disorders Dehydration	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	4.3% 2/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Metabolism and nutrition disorders Hypoalbuminemia	4.8% 1/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Metabolism and nutrition disorders Hyponatremia	4.8% 1/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Psychiatric disorders Confusional state	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Psychiatric disorders Personality change	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Renal and urinary disorders Bladder pain	4.8% 1/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Renal and urinary disorders Ureteric stenosis	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Renal and urinary disorders Urethral pain	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Aspiration	4.8% 1/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis NOS	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Vascular disorders Hematoma	4.8% 1/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Vascular disorders Hypotension NOS	4.8% 1/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Vascular disorders Thrombosis	0.00% 0/21 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	2.1% 1/47 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.