Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane Therapy
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00063570
First received: June 30, 2003
Last updated: May 12, 2009
Last verified: May 2009
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Results First Received: January 27, 2009
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Breast Cancer Breast Neoplasms |
| Interventions: |
Drug: Pemetrexed Drug: Gemcitabine |
Participant Flow
Hide Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| At completion of the first stage of the trial, toxicities associated with the Day 8 dosing of gemcitabine were observed, and the protocol was amended to a bi-weekly schedule. Patients were analyzed separately according to the study drug schedule received. |
Reporting Groups
| Description | |
|---|---|
| Bi-Weekly Schedule |
Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression. Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression. |
| 21-Day Schedule |
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression. Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression. |
Participant Flow: Overall Study
| Bi-Weekly Schedule | 21-Day Schedule | |
|---|---|---|
| STARTED | 52 | 21 |
| COMPLETED | 52 [1] | 21 [1] |
| NOT COMPLETED | 0 | 0 |
| [1] | Completed for this study means patient received study drug and was eligible for efficacy analysis. |
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Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Bi-Weekly Schedule |
Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression. Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression. |
| 21-Day Schedule |
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression. Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression. |
| Total | Total of all reporting groups |
Baseline Measures
| Bi-Weekly Schedule | 21-Day Schedule | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
52 | 21 | 73 |
|
Age
[units: years] Median (Full Range) |
53.5
(33 to 73) |
50.7
(28 to 73) |
51.9
(28 to 73) |
|
Gender
[units: participants] |
|||
| Female | 52 | 21 | 73 |
| Male | 0 | 0 | 0 |
|
Region of Enrollment
[units: participants] |
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| United States | 52 | 21 | 73 |
|
Current Pathological Diagnosis
[units: paticipants] |
|||
| Ductal breast carcinoma | 36 | 12 | 48 |
| Lobular breast carcinoma | 2 | 0 | 2 |
| Adenocystic breast carcinoma | 0 | 1 | 1 |
| Breast carcinoma | 4 | 4 | 8 |
| Other | 7 | 3 | 10 |
| Unknown | 1 | 1 | 2 |
| No current pathological diagnosis | 2 | 0 | 2 |
|
Karnofsky Performance Status (KPS)
[1] [units: participants] |
|||
| <=60 - Needs increasing assistance up to Death (0) | 0 | 0 | 0 |
| 70 - Unable to carry on normal activity | 4 | 1 | 5 |
| 80 - Activity with effort; some signs of disease | 11 | 5 | 16 |
| 90 - Normal activity; minor signs of disease | 19 | 9 | 28 |
| 100 - Normal no complaints; no evidence of disease | 17 | 6 | 23 |
| unknown | 1 | 0 | 1 |
|
Menopausal Status at Cycle 0
[units: participants] |
|||
| Pre-Menopausal | 7 | 3 | 10 |
| Menopausal | 4 | 3 | 7 |
| Post-Menopausal | 41 | 15 | 56 |
|
Patients with Current Pathological Diagnosis
[units: participants] |
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| Yes | 50 | 21 | 71 |
| No | 2 | 0 | 2 |
|
Race/Ethnicity
[units: participants] |
|||
| Caucasian | 44 | 20 | 64 |
| African | 4 | 1 | 5 |
| East/Southeast Asian | 3 | 0 | 3 |
| Hispanic | 1 | 0 | 1 |
|
Time (in months) from Current Pathological Diagnosis to Enrollment
[units: Months] Median (Full Range) |
13.08
(0.4 to 134.2) |
14.31
(0.5 to 57.1) |
14.29
(0.4 to 134.2) |
| [1] | The Karnofsky Performance Status Index classifies functional impairment. Scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. |
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Outcome Measures
Show All Outcome Measures
| 1. Primary: | Overall Tumor Response [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ] |
| 2. Secondary: | Duration of (Confirmed) Complete Response or Partial Response [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ] |
| 3. Secondary: | Time to Progressive Disease [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ] |
| 4. Secondary: | Time to Treatment Failure [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ] |
| 5. Secondary: | Overall Survival [ Time Frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated ] |
Serious Adverse Events| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Reporting Groups
| Description | |
|---|---|
| Bi-Weekly Schedule |
Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression. Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression. |
| 21-Day Schedule |
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression. Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression. |
Serious Adverse Events
| Bi-Weekly Schedule | 21-Day Schedule | |
|---|---|---|
| Total, serious adverse events | ||
| # participants affected | 17 | 7 |
| Blood and lymphatic system disorders | ||
| Anaemia † 1 | ||
| # participants affected / at risk | 2/52 (3.85%) | 0/21 (0.00%) |
| # events | 2 | 0 |
| Febrile neutropenia † 1 | ||
| # participants affected / at risk | 4/52 (7.69%) | 1/21 (4.76%) |
| # events | 5 | 1 |
| Pancytopenia † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Thrombocytopenia † 1 | ||
| # participants affected / at risk | 0/52 (0.00%) | 1/21 (4.76%) |
| # events | 0 | 1 |
| Gastrointestinal disorders | ||
| Abdominal pain † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Constipation † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| General disorders | ||
| Pyrexia † 1 | ||
| # participants affected / at risk | 2/52 (3.85%) | 1/21 (4.76%) |
| # events | 3 | 1 |
| Hepatobiliary disorders | ||
| Hepatic failure † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 2 | 0 |
| Hyperbilirubinaemia † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Infections and infestations | ||
| Device related infection † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Pneumonia † 1 | ||
| # participants affected / at risk | 2/52 (3.85%) | 0/21 (0.00%) |
| # events | 2 | 0 |
| Sepsis † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Injury, poisoning and procedural complications | ||
| Femur fracture † 1 | ||
| # participants affected / at risk | 0/52 (0.00%) | 1/21 (4.76%) |
| # events | 0 | 1 |
| Fracture † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Spinal compression fracture † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Investigations | ||
| Drug level increased † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Metabolism and nutrition disorders | ||
| Dehydration † 1 | ||
| # participants affected / at risk | 2/52 (3.85%) | 0/21 (0.00%) |
| # events | 2 | 0 |
| Hyponatraemia † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Hypovolaemia † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Malignant neoplasm progression † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Nervous system disorders | ||
| Convulsion † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Dizziness † 1 | ||
| # participants affected / at risk | 0/52 (0.00%) | 1/21 (4.76%) |
| # events | 0 | 1 |
| Lumbar radiculopathy † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Meningitis noninfective † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Psychiatric disorders | ||
| Mental status changes † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnoea † 1 | ||
| # participants affected / at risk | 0/52 (0.00%) | 1/21 (4.76%) |
| # events | 0 | 1 |
| Interstitial lung disease † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Pleural effusion † 1 | ||
| # participants affected / at risk | 2/52 (3.85%) | 0/21 (0.00%) |
| # events | 2 | 0 |
| Pneumonitis † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Pulmonary embolism † 1 | ||
| # participants affected / at risk | 0/52 (0.00%) | 1/21 (4.76%) |
| # events | 0 | 1 |
| Pulmonary oedema † 1 | ||
| # participants affected / at risk | 0/52 (0.00%) | 1/21 (4.76%) |
| # events | 0 | 1 |
| Respiratory failure † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Skin and subcutaneous tissue disorders | ||
| Drug eruption † 1 | ||
| # participants affected / at risk | 1/52 (1.92%) | 0/21 (0.00%) |
| # events | 1 | 0 |
| Erythema † 1 | ||
| # participants affected / at risk | 0/52 (0.00%) | 1/21 (4.76%) |
| # events | 0 | 1 |
| Vascular disorders | ||
| Aortic stenosis † 1 | ||
| # participants affected / at risk | 0/52 (0.00%) | 1/21 (4.76%) |
| # events | 0 | 1 |
| Superior vena caval occlusion † 1 | ||
| # participants affected / at risk | 0/52 (0.00%) | 1/21 (4.76%) |
| # events | 0 | 1 |
| † | Events were collected by systematic assessment |
|---|---|
| 1 | Term from vocabulary, MedDRA 10 |
Other Adverse Events
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |