Trial Outcomes & Findings for Irinotecan and Etoposide in Treating Patients With Recurrent, Locally Advanced, or Metastatic Breast Cancer (NCT NCT00693719)
NCT ID: NCT00693719
Last Updated: 2015-11-20
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months
Results posted on
2015-11-20
Participant Flow
Participant milestones
| Measure |
Etoposide/Irinotecan
Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Irinotecan and Etoposide in Treating Patients With Recurrent, Locally Advanced, or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Etoposide/Irinotecan
n=31 Participants
Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
54.68 years
STANDARD_DEVIATION 11.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 monthsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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
| Measure |
Etoposide/Irinotecan
n=31 Participants
Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
|
|---|---|
|
Median Time to Progression
|
149 Days
Standard Error 33.83
|
SECONDARY outcome
Timeframe: Measured from the start of protocol therapy until the date of death from any cause or will be censored at the date the patient was last known to be alive, assesed up to 13 monthsStill alive for a certain period of time after they were diagnosed with or started treatment
Outcome measures
| Measure |
Etoposide/Irinotecan
n=31 Participants
Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
|
|---|---|
|
Overall Survival
|
149 Days
Interval 82.703 to 215.297
|
Adverse Events
Etoposide/Irinotecan
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etoposide/Irinotecan
n=31 participants at risk
Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
|
|---|---|
|
Gastrointestinal disorders
Pain
|
6.5%
2/31 • Number of events 3 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Dehydration
|
3.2%
1/31 • Number of events 1 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Dyspnea
|
3.2%
1/31 • Number of events 1 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Blood and lymphatic system disorders
Bleeding
|
3.2%
1/31 • Number of events 1 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
Other adverse events
| Measure |
Etoposide/Irinotecan
n=31 participants at risk
Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
71.0%
22/31 • Number of events 36 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
41.9%
13/31 • Number of events 33 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Vomiting
|
32.3%
10/31 • Number of events 18 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Anorexia
|
19.4%
6/31 • Number of events 7 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Constipation
|
19.4%
6/31 • Number of events 7 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
19.4%
6/31 • Number of events 6 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
12.9%
4/31 • Number of events 4 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Dehydration
|
12.9%
4/31 • Number of events 5 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
12.9%
4/31 • Number of events 7 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
12.9%
4/31 • Number of events 11 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
9.7%
3/31 • Number of events 3 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
9.7%
3/31 • Number of events 3 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.7%
3/31 • Number of events 4 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
80.6%
25/31 • Number of events 78 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
67.7%
21/31 • Number of events 74 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
61.3%
19/31 • Number of events 77 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Blood and lymphatic system disorders
Platelets
|
35.5%
11/31 • Number of events 34 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
48.4%
15/31 • Number of events 40 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
41.9%
13/31 • Number of events 34 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
38.7%
12/31 • Number of events 19 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
35.5%
11/31 • Number of events 18 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
35.5%
11/31 • Number of events 23 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
29.0%
9/31 • Number of events 17 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
19.4%
6/31 • Number of events 7 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
16.1%
5/31 • Number of events 11 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
6.5%
2/31 • Number of events 13 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Pain - Other (Specify, __)
|
32.3%
10/31 • Number of events 15 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Pain - Abdomen NOS
|
25.8%
8/31 • Number of events 17 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Pain - Bone
|
22.6%
7/31 • Number of events 9 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Pain - Throat/pharynx/larynx
|
16.1%
5/31 • Number of events 7 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Pain - Back
|
12.9%
4/31 • Number of events 5 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Pain - Pelvis
|
12.9%
4/31 • Number of events 6 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Pain - Chest/thorax NOS
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Pain - Extremity-limb
|
6.5%
2/31 • Number of events 4 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Pain - Head/headache
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Pain - Joint
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Pain- Rectum
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Pain - Stomach
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
45.2%
14/31 • Number of events 21 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Weight loss
|
12.9%
4/31 • Number of events 4 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Insomnia
|
9.7%
3/31 • Number of events 3 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
6.5%
2/31 • Number of events 3 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Sweating (diaphoresis)
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Dizziness
|
19.4%
6/31 • Number of events 6 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Confusion
|
9.7%
3/31 • Number of events 4 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Neuropathy: sensory
|
9.7%
3/31 • Number of events 3 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
6.5%
2/31 • Number of events 5 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
General disorders
Neurology - Other (Specify, __)
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
32.3%
10/31 • Number of events 17 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.6%
7/31 • Number of events 7 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
6.5%
2/31 • Number of events 3 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
6.5%
2/31 • Number of events 3 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Infections and infestations
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Infections and infestations
Infection - Other (Specify, __)
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Infections and infestations
Infection with unknown ANC - Upper airway NOS
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
12.9%
4/31 • Number of events 5 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Skin and subcutaneous tissue disorders
Flushing
|
9.7%
3/31 • Number of events 5 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
9.7%
3/31 • Number of events 5 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Blood and lymphatic system disorders
Edema: limb
|
16.1%
5/31 • Number of events 6 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
6.5%
2/31 • Number of events 3 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Endocrine disorders
Hot flashes/flushes
|
9.7%
3/31 • Number of events 3 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
6.5%
2/31 • Number of events 2 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Cardiac disorders
Cardiopulmonary arrest, cause unknown (non-fatal)
|
6.5%
2/31 • Number of events 3 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
6.5%
2/31 • Number of events 3 • Adverse events were assessed at the end of each 28-day cycle of treatment
|
Additional Information
Dr. Robert Livingston
University of Arizona Cancer Center
Phone: 520/626-4175
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place