Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00106002
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arm: 1
• Duration (Months): 32
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer. The collection of DNA is optional to the patient.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Breast Neoplasms, Male; Carcinoma, Ductal	Drug: pemetrexed	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: pemetrexed; 600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression; Other Names: LY231514 Alimta

Outcome Measures

Primary Outcome Measures

1. Overall Tumor Response [every 3 cycles (approximately 6-7 weeks) or until patient has disease progression]

   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.

Secondary Outcome Measures

1. Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) [every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up]

   Participants 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).

2. Duration of Tumor Response [every 3 cycles (approximately 6-7 weeks) or until patient has disease progression]

   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.

3. Progression-Free Survival Time [every 3 cycles (approximately 6-7 weeks) or until patient has disease progression]

   Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.

4. Overall Survival Time [every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up]

   Defined as the time from date of first dose to time of death due to any cause.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must have been diagnosed with either advanced or metastatic breast cancer.

• Chemotherapy has not been given for advanced or metastatic breast cancer.

• The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery.

• Able to carry out work of a light nature (for example, light housework, office work).

• Must be at least 18 years old.

Exclusion Criteria:

• Have received prior bone marrow or peripheral stem cell transplantation.

• Have received prior chemotherapy for metastatic breast cancer.

• Are currently pregnant or breast-feeding.

• Have an active infection that your doctor decides will affect your safety.

• Are unable to take folic acid or vitamin B12.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Dallas	Texas	United States	75204

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Lilly Clinical Trial Registry

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00106002
• Other Study ID Numbers: 9028; H3E-US-S045
• First Posted: Mar 21, 2005
• Last Update Posted: Jun 1, 2009
• Last Verified: Apr 1, 2009

• Additional relevant MeSH terms: Breast Neoplasms; Carcinoma, Ductal; Breast Neoplasms, Male; Pemetrexed

Study Results

Participant Flow

Arm/Group Title	Pemetrexed
Arm/Group Description	600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
Period Title: Overall Study
STARTED	37
COMPLETED	35
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Pemetrexed
Arm/Group Description	600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
Overall Participants	37
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	61.4
Sex: Female, Male (Count of Participants)
Female	37 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	37 100%
Eastern Cooperative Oncology Group Scale Performance Status (participants) [Number]
0 - Fully Active	19 51.4%
1 - Ambulatory, Restricted Strenuous Activity	18 48.6%
2 - Ambulatory, No Work Activities	0 0%
3 - Partially Confined to Bed, Limited Self Care	0 0%
4 - Completely Disabled	0 0%

Outcome Measures

1. Primary Outcome

Title	Overall Tumor Response
Description	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.
Time Frame	every 3 cycles (approximately 6-7 weeks) or until patient has disease progression

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pemetrexed
Arm/Group Description	600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
Measure Participants	35
Complete Response	1 2.7%
Partial Response	8 21.6%
Stable Disease	14 37.8%
Progressive Disease	9 24.3%
Best Response Not Evaluable	3 8.1%

2. Secondary Outcome

Title	Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Description	Participants 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).
Time Frame	every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pemetrexed
Arm/Group Description	600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
Measure Participants	36
Anaemia - Grade 3	5 13.5%
Anaemia - Grade 4	0 0%
Leukopenia - Grade 3	4 10.8%
Leukopenia - Grade 4	2 5.4%
Neutropenia - Grade 3	8 21.6%
Neutropenia - Grade 4	5 13.5%
Constipation - Grade 3	2 5.4%
Constipation - Grade 4	0 0%
Nausea - Grade 3	3 8.1%
Nausea - Grade 4	0 0%
Asthenia - Grade 3	3 8.1%
Asthenia - Grade 4	0 0%
Fatigue - Grade 3	5 13.5%
Fatigue - Grade 4	0 0%
Cellulitis - Grade 3	2 5.4%
Cellulitis - Grade 4	0 0%
Dehydration - Grade 3	2 5.4%
Dehydration - Grade 4	0 0%
Hyperglycaemia - Grade 3	3 8.1%
Hyperglycaemia - Grade 4	2 5.4%
Dyspnoea - Grade 3	4 10.8%
Dyspnoea - Grade 4	0 0%
Pleural effusion - Grade 3	2 5.4%
Pleural effusion - Grade 4	0 0%

3. Secondary Outcome

Title	Duration of Tumor Response
Description	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.
Time Frame	every 3 cycles (approximately 6-7 weeks) or until patient has disease progression

Outcome Measure Data

Analysis Population Description

Only applies to patients who had a complete or partial response

Arm/Group Title	Pemetrexed
Arm/Group Description	600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
Measure Participants	9
Median (Full Range) [months]	7.3

4. Secondary Outcome

Title	Progression-Free Survival Time
Description	Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Time Frame	every 3 cycles (approximately 6-7 weeks) or until patient has disease progression

Outcome Measure Data

Analysis Population Description

Intent to treat population (in order to follow protocol, one patient who did not take study drug was excluded from this analysis)

Arm/Group Title	Pemetrexed
Arm/Group Description	600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
Measure Participants	36
Median (Full Range) [months]	4.1

5. Secondary Outcome

Title	Overall Survival Time
Description	Defined as the time from date of first dose to time of death due to any cause.
Time Frame	every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up

Outcome Measure Data

Analysis Population Description

Intent to treat population (in order to follow protocol, one patient who did not take any study drug was excluded from this analysis)

Arm/Group Title	Pemetrexed
Arm/Group Description	600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
Measure Participants	36
Median (Full Range) [months]	18.9

Adverse Events

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed
All Cause Mortality
	Pemetrexed
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pemetrexed
	Affected / at Risk (%)	# Events
Total	14/ (NaN)
Blood and lymphatic system disorders
Anaemia	2/36 (5.6%)	2
Febrile neutropenia	1/36 (2.8%)	1
Cardiac disorders
Angina pectoris	1/36 (2.8%)	1
Gastrointestinal disorders
Abdominal pain upper	1/36 (2.8%)	1
Diarrhoea	1/36 (2.8%)	1
Nausea	3/36 (8.3%)	3
Vomiting	2/36 (5.6%)	2
General disorders
Asthenia	1/36 (2.8%)	1
Fatigue	1/36 (2.8%)	1
Infections and infestations
Cellulitis	2/36 (5.6%)	5
Peritonitis bacterial	1/36 (2.8%)	1
Upper respiratory tract infection	1/36 (2.8%)	1
Urinary tract infection	1/36 (2.8%)	1
Investigations
Blood creatinine increased	1/36 (2.8%)	1
Nutritional condition abnormal	1/36 (2.8%)	1
Metabolism and nutrition disorders
Dehydration	1/36 (2.8%)	1
Musculoskeletal and connective tissue disorders
Back pain	1/36 (2.8%)	1
Muscular weakness	1/36 (2.8%)	1
Nervous system disorders
Dizziness	2/36 (5.6%)	2
Psychiatric disorders
Mental status changes	2/36 (5.6%)	2
Respiratory, thoracic and mediastinal disorders
Bronchospasm	1/36 (2.8%)	1
Dyspnoea	2/36 (5.6%)	2
Pleural effusion	2/36 (5.6%)	2
Skin and subcutaneous tissue disorders
Decubitus ulcer	1/36 (2.8%)	1
Vascular disorders
Lymphoedema	1/36 (2.8%)	2
Visceral arterial ischaemia	1/36 (2.8%)	1
Other (Not Including Serious) Adverse Events
	Pemetrexed
	Affected / at Risk (%)	# Events
Total	34/ (NaN)
Blood and lymphatic system disorders
Anaemia	26/36 (72.2%)	78
Leukopenia	12/36 (33.3%)	36
Lymphopenia	3/36 (8.3%)	4
Neutropenia	21/36 (58.3%)	51
Thrombocytopenia	6/36 (16.7%)	10
Cardiac disorders
Palpitations	2/36 (5.6%)	2
Tachycardia	3/36 (8.3%)	3
Eye disorders
Eye irritation	2/36 (5.6%)	2
Lacrimation increased	2/36 (5.6%)	2
Vision blurred	3/36 (8.3%)	3
Gastrointestinal disorders
Abdominal pain	7/36 (19.4%)	7
Ascites	2/36 (5.6%)	2
Constipation	10/36 (27.8%)	13
Diarrhoea	9/36 (25%)	13
Dry mouth	2/36 (5.6%)	2
Gastrooesophageal reflux disease	2/36 (5.6%)	2
Nausea	18/36 (50%)	41
Oral pain	2/36 (5.6%)	2
Stomatitis	2/36 (5.6%)	2
Vomiting	9/36 (25%)	16
General disorders
Asthenia	6/36 (16.7%)	11
Chills	2/36 (5.6%)	2
Fatigue	26/36 (72.2%)	47
Generalised oedema	3/36 (8.3%)	5
Mucosal inflammation	4/36 (11.1%)	5
Oedema peripheral	8/36 (22.2%)	12
Pain	2/36 (5.6%)	3
Pyrexia	5/36 (13.9%)	7
Infections and infestations
Cellulitis	3/36 (8.3%)	5
Rhinitis	2/36 (5.6%)	2
Sinusitis	4/36 (11.1%)	5
Upper respiratory tract infection	3/36 (8.3%)	3
Urinary tract infection	5/36 (13.9%)	7
Injury, poisoning and procedural complications
Contusion	3/36 (8.3%)	3
Investigations
Alanine aminotransferase	2/36 (5.6%)	3
Alanine aminotransferase increased	10/36 (27.8%)	16
Aspartate aminotransferase	2/36 (5.6%)	3
Aspartate aminotransferase increased	9/36 (25%)	17
Blood alkaline phosphatase increased	4/36 (11.1%)	7
Blood glucose increased	2/36 (5.6%)	7
Blood lactate dehydrogenase increased	3/36 (8.3%)	3
Weight decreased	4/36 (11.1%)	5
White blood cell count increased	2/36 (5.6%)	3
Metabolism and nutrition disorders
Anorexia	11/36 (30.6%)	16
Decreased appetite	2/36 (5.6%)	2
Dehydration	2/36 (5.6%)	2
Hyperglycaemia	8/36 (22.2%)	21
Hypoalbuminaemia	3/36 (8.3%)	4
Hypokalaemia	3/36 (8.3%)	6
Hyponatraemia	2/36 (5.6%)	4
Musculoskeletal and connective tissue disorders
Arthralgia	3/36 (8.3%)	3
Back pain	4/36 (11.1%)	5
Musculoskeletal chest pain	2/36 (5.6%)	3
Myalgia	5/36 (13.9%)	6
Pain in extremity	3/36 (8.3%)	4
Nervous system disorders
Coordination abnormal	2/36 (5.6%)	2
Dizziness	7/36 (19.4%)	9
Dysgeusia	2/36 (5.6%)	2
Headache	8/36 (22.2%)	8
Paraesthesia	3/36 (8.3%)	4
Tremor	2/36 (5.6%)	2
Psychiatric disorders
Anxiety	5/36 (13.9%)	5
Depression	5/36 (13.9%)	7
Insomnia	8/36 (22.2%)	8
Reproductive system and breast disorders
Breast pain	2/36 (5.6%)	2
Vaginal haemorrhage	2/36 (5.6%)	3
Respiratory, thoracic and mediastinal disorders
Cough	5/36 (13.9%)	5
Dyspnoea	9/36 (25%)	12
Epistaxis	2/36 (5.6%)	2
Pharyngolaryngeal pain	2/36 (5.6%)	2
Skin and subcutaneous tissue disorders
Alopecia	4/36 (11.1%)	4
Erythema	3/36 (8.3%)	3
Pruritus	2/36 (5.6%)	2
Rash	10/36 (27.8%)	13
Skin hyperpigmentation	2/36 (5.6%)	2
Swelling face	2/36 (5.6%)	2
Vascular disorders
Hot flush	4/36 (11.1%)	4
Hypotension	2/36 (5.6%)	2
Lymphoedema	4/36 (11.1%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.