Trial Outcomes & Findings for Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment (NCT NCT00710970)
NCT ID: NCT00710970
Last Updated: 2022-01-24
Results Overview
Clinical Assessments were performed every 4 weeks and imaging every 8 weeks or earlier if indicated. Patients were followed every month for clinical symptoms and signs of progression. Patients underwent Radiographic CT scans every 8 weeks to look for progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Estimated from date of starting therapy until 4 months but up to progression or death which ever comes first.
Results posted on
2022-01-24
Participant Flow
Patients presenting to the Scott Department of Urology for management of recurrent bladder cancer and fulfill the following criteria will be recruited.
Participant milestones
| Measure |
Single Arm Receiving 20mg Tamoxifen
Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Single Arm Receiving 20mg Tamoxifen
Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
|
|---|---|
|
Overall Study
Never took drug
|
3
|
Baseline Characteristics
Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment
Baseline characteristics by cohort
| Measure |
Single Arm Receiving 20mg Tamoxifen
n=28 Participants
Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 10.844 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Estimated from date of starting therapy until 4 months but up to progression or death which ever comes first.Clinical Assessments were performed every 4 weeks and imaging every 8 weeks or earlier if indicated. Patients were followed every month for clinical symptoms and signs of progression. Patients underwent Radiographic CT scans every 8 weeks to look for progression.
Outcome measures
| Measure |
Single Arm Receiving 25mg Tamoxifen
n=20 Participants
Tamoxifen: Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
|
|---|---|
|
Number of Participants With Freedom From Progression of Cancer at 4 Months
|
20 Participants
|
Adverse Events
Single Arm Receiving 20mg Tamoxifen
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm Receiving 20mg Tamoxifen
n=19 participants at risk
Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
|
|---|---|
|
Renal and urinary disorders
Acute Renal Failure
|
10.5%
2/19
|
Other adverse events
| Measure |
Single Arm Receiving 20mg Tamoxifen
n=19 participants at risk
Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
|
|---|---|
|
Immune system disorders
Allergic Rhinitis
|
5.3%
1/19
|
|
Blood and lymphatic system disorders
anemia
|
31.6%
6/19
|
|
Blood and lymphatic system disorders
Decreased hematocrit
|
26.3%
5/19
|
|
Blood and lymphatic system disorders
Decreased hemoglobin
|
21.1%
4/19
|
|
Blood and lymphatic system disorders
Decreased lymphocytes
|
21.1%
4/19
|
|
Blood and lymphatic system disorders
Decreased Red Blood Cells
|
5.3%
1/19
|
|
Blood and lymphatic system disorders
Decreased White Blood Cells
|
5.3%
1/19
|
|
Blood and lymphatic system disorders
Increased Granulocytes
|
5.3%
1/19
|
|
Blood and lymphatic system disorders
Increased Monocytes
|
5.3%
1/19
|
|
Blood and lymphatic system disorders
Increased neutrophil
|
5.3%
1/19
|
|
Blood and lymphatic system disorders
Increased White Blood Cell
|
15.8%
3/19
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.5%
2/19
|
|
Blood and lymphatic system disorders
Chest Pain
|
5.3%
1/19
|
|
Cardiac disorders
Hypertension
|
5.3%
1/19
|
|
Cardiac disorders
Hypotension
|
5.3%
1/19
|
|
Investigations
Fatigue
|
21.1%
4/19
|
|
Endocrine disorders
Hot Flashes
|
5.3%
1/19
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19
|
|
Gastrointestinal disorders
Flatuence
|
5.3%
1/19
|
|
Gastrointestinal disorders
Constipation
|
10.5%
2/19
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19
|
|
Gastrointestinal disorders
Vomitting
|
5.3%
1/19
|
|
Gastrointestinal disorders
Anorexia
|
5.3%
1/19
|
|
Gastrointestinal disorders
Ascites
|
5.3%
1/19
|
|
Infections and infestations
Sepsis
|
5.3%
1/19
|
|
Infections and infestations
Sinus Infection
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Decreased Alk Phos
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Decreased ALT
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.8%
3/19
|
|
Metabolism and nutrition disorders
Increased Albumin
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Increased Alk Phos
|
26.3%
5/19
|
|
Metabolism and nutrition disorders
Increased Bilirubin
|
5.3%
1/19
|
|
Investigations
Increased BUN
|
15.8%
3/19
|
|
Investigations
Increased Creatinine
|
31.6%
6/19
|
|
Investigations
Increased ferritin
|
5.3%
1/19
|
|
Investigations
Increased SGOT
|
15.8%
3/19
|
|
Nervous system disorders
Dizziness
|
21.1%
4/19
|
|
Nervous system disorders
Neuropathy
|
5.3%
1/19
|
|
Nervous system disorders
Syncope
|
5.3%
1/19
|
|
General disorders
Pain in Anus
|
5.3%
1/19
|
|
General disorders
Pain in upper thigh
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.3%
1/19
|
|
Renal and urinary disorders
Dysuria
|
5.3%
1/19
|
|
Renal and urinary disorders
Hematuria
|
5.3%
1/19
|
|
Renal and urinary disorders
Hydronephrosis
|
5.3%
1/19
|
|
Renal and urinary disorders
Pyleonephritis
|
5.3%
1/19
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19
|
Additional Information
Seth P. Lerner, M.D., F. A. C. S.
Baylor College of Medicine
Phone: 713-798-6841
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place