Trial Outcomes & Findings for Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer (NCT NCT00106002)
NCT ID: NCT00106002
Last Updated: 2009-06-01
Results Overview
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
Results posted on
2009-06-01
Participant Flow
Participant milestones
| Measure |
Pemetrexed
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Pemetrexed
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
|
|---|---|
|
Overall Study
Did not take any study drug
|
1
|
|
Overall Study
Ineligible after Registration
|
1
|
Baseline Characteristics
Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed
n=37 Participants
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
|
|---|---|
|
Age Continuous
|
61.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Scale Performance Status
0 - Fully Active
|
19 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Scale Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
18 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Scale Performance Status
2 - Ambulatory, No Work Activities
|
0 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Scale Performance Status
3 - Partially Confined to Bed, Limited Self Care
|
0 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Scale Performance Status
4 - Completely Disabled
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 3 cycles (approximately 6-7 weeks) or until patient has disease progressionBest response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Outcome measures
| Measure |
Pemetrexed
n=35 Participants
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
|
|---|---|
|
Overall Tumor Response
Complete Response
|
1 participants
|
|
Overall Tumor Response
Stable Disease
|
14 participants
|
|
Overall Tumor Response
Progressive Disease
|
9 participants
|
|
Overall Tumor Response
Best Response Not Evaluable
|
3 participants
|
|
Overall Tumor Response
Partial Response
|
8 participants
|
SECONDARY outcome
Timeframe: every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-upParticipants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grades range from 0 (no AE or within normal limits) to 5 (death related to AE).
Outcome measures
| Measure |
Pemetrexed
n=36 Participants
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
|
|---|---|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Anaemia - Grade 3
|
5 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Anaemia - Grade 4
|
0 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Leukopenia - Grade 3
|
4 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Leukopenia - Grade 4
|
2 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Neutropenia - Grade 3
|
8 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Neutropenia - Grade 4
|
5 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Constipation - Grade 3
|
2 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Constipation - Grade 4
|
0 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Nausea - Grade 3
|
3 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Nausea - Grade 4
|
0 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Asthenia - Grade 3
|
3 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Asthenia - Grade 4
|
0 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Fatigue - Grade 3
|
5 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Fatigue - Grade 4
|
0 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Cellulitis - Grade 3
|
2 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Cellulitis - Grade 4
|
0 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Dehydration - Grade 3
|
2 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Dehydration - Grade 4
|
0 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Hyperglycaemia - Grade 3
|
3 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Hyperglycaemia - Grade 4
|
2 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Dyspnoea - Grade 3
|
4 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Dyspnoea - Grade 4
|
0 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Pleural effusion - Grade 3
|
2 participants
|
|
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Pleural effusion - Grade 4
|
0 participants
|
SECONDARY outcome
Timeframe: every 3 cycles (approximately 6-7 weeks) or until patient has disease progressionPopulation: Only applies to patients who had a complete or partial response
Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause.
Outcome measures
| Measure |
Pemetrexed
n=9 Participants
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
|
|---|---|
|
Duration of Tumor Response
|
7.3 months
Interval 3.0 to 20.6
|
SECONDARY outcome
Timeframe: every 3 cycles (approximately 6-7 weeks) or until patient has disease progressionPopulation: Intent to treat population (in order to follow protocol, one patient who did not take study drug was excluded from this analysis)
Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Outcome measures
| Measure |
Pemetrexed
n=36 Participants
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
|
|---|---|
|
Progression-Free Survival Time
|
4.1 months
Interval 0.5 to 22.4
|
SECONDARY outcome
Timeframe: every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-upPopulation: Intent to treat population (in order to follow protocol, one patient who did not take any study drug was excluded from this analysis)
Defined as the time from date of first dose to time of death due to any cause.
Outcome measures
| Measure |
Pemetrexed
n=36 Participants
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
|
|---|---|
|
Overall Survival Time
|
18.9 months
Interval 0.5 to 27.7
|
Adverse Events
Pemetrexed
Serious events: 14 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed
Pemetrexed
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
2/36 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
8.3%
3/36 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Asthenia
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Fatigue
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
5.6%
2/36 • Number of events 5
|
|
Infections and infestations
Peritonitis bacterial
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Nutritional condition abnormal
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
5.6%
2/36 • Number of events 2
|
|
Psychiatric disorders
Mental status changes
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.8%
1/36 • Number of events 1
|
|
Vascular disorders
Lymphoedema
|
2.8%
1/36 • Number of events 2
|
|
Vascular disorders
Visceral arterial ischaemia
|
2.8%
1/36 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed
Pemetrexed
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
72.2%
26/36 • Number of events 78
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
12/36 • Number of events 36
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.3%
3/36 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutropenia
|
58.3%
21/36 • Number of events 51
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
6/36 • Number of events 10
|
|
Cardiac disorders
Palpitations
|
5.6%
2/36 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
8.3%
3/36 • Number of events 3
|
|
Eye disorders
Eye irritation
|
5.6%
2/36 • Number of events 2
|
|
Eye disorders
Lacrimation increased
|
5.6%
2/36 • Number of events 2
|
|
Eye disorders
Vision blurred
|
8.3%
3/36 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
19.4%
7/36 • Number of events 7
|
|
Gastrointestinal disorders
Ascites
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
27.8%
10/36 • Number of events 13
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
9/36 • Number of events 13
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
50.0%
18/36 • Number of events 41
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
9/36 • Number of events 16
|
|
General disorders
Asthenia
|
16.7%
6/36 • Number of events 11
|
|
General disorders
Chills
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Fatigue
|
72.2%
26/36 • Number of events 47
|
|
General disorders
Generalised oedema
|
8.3%
3/36 • Number of events 5
|
|
General disorders
Mucosal inflammation
|
11.1%
4/36 • Number of events 5
|
|
General disorders
Oedema peripheral
|
22.2%
8/36 • Number of events 12
|
|
General disorders
Pain
|
5.6%
2/36 • Number of events 3
|
|
General disorders
Pyrexia
|
13.9%
5/36 • Number of events 7
|
|
Infections and infestations
Cellulitis
|
8.3%
3/36 • Number of events 5
|
|
Infections and infestations
Rhinitis
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
11.1%
4/36 • Number of events 5
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
3/36 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
13.9%
5/36 • Number of events 7
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
3/36 • Number of events 3
|
|
Investigations
Alanine aminotransferase
|
5.6%
2/36 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
27.8%
10/36 • Number of events 16
|
|
Investigations
Aspartate aminotransferase
|
5.6%
2/36 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
9/36 • Number of events 17
|
|
Investigations
Blood alkaline phosphatase increased
|
11.1%
4/36 • Number of events 7
|
|
Investigations
Blood glucose increased
|
5.6%
2/36 • Number of events 7
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.3%
3/36 • Number of events 3
|
|
Investigations
Weight decreased
|
11.1%
4/36 • Number of events 5
|
|
Investigations
White blood cell count increased
|
5.6%
2/36 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
30.6%
11/36 • Number of events 16
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
2/36 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
2/36 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
22.2%
8/36 • Number of events 21
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.3%
3/36 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
3/36 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.6%
2/36 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
3/36 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
4/36 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.6%
2/36 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.9%
5/36 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
3/36 • Number of events 4
|
|
Nervous system disorders
Coordination abnormal
|
5.6%
2/36 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
19.4%
7/36 • Number of events 9
|
|
Nervous system disorders
Dysgeusia
|
5.6%
2/36 • Number of events 2
|
|
Nervous system disorders
Headache
|
22.2%
8/36 • Number of events 8
|
|
Nervous system disorders
Paraesthesia
|
8.3%
3/36 • Number of events 4
|
|
Nervous system disorders
Tremor
|
5.6%
2/36 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
13.9%
5/36 • Number of events 5
|
|
Psychiatric disorders
Depression
|
13.9%
5/36 • Number of events 7
|
|
Psychiatric disorders
Insomnia
|
22.2%
8/36 • Number of events 8
|
|
Reproductive system and breast disorders
Breast pain
|
5.6%
2/36 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.6%
2/36 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.9%
5/36 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
9/36 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
4/36 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.3%
3/36 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.8%
10/36 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
5.6%
2/36 • Number of events 2
|
|
Vascular disorders
Hot flush
|
11.1%
4/36 • Number of events 4
|
|
Vascular disorders
Hypotension
|
5.6%
2/36 • Number of events 2
|
|
Vascular disorders
Lymphoedema
|
11.1%
4/36 • Number of events 9
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60