Trial Outcomes & Findings for A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer (NCT NCT00383266)
NCT ID: NCT00383266
Last Updated: 2016-01-11
Results Overview
* Overall response rate = complete response (CR) + partial response (PR) using RECIST. * CR=disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level * PR=at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Until patient progresses or dies (median follow-up 293 days -- range (63-632 days)
Results posted on
2016-01-11
Participant Flow
The study opened to participant enrollment on 10/11/2006 and closed to participant enrollment on 11/12/2009.
Participant milestones
| Measure |
Pemetrexed + Carboplatin
* Pemetrexed 500 mg/m\^2 IV over 10 minutes
* Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
* Each cycle will last 21 days.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed + Carboplatin
n=9 Participants
* Pemetrexed 500 mg/m2 IV over 10 minutes
* Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
* Each cycle will last 21 days.
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until patient progresses or dies (median follow-up 293 days -- range (63-632 days)* Overall response rate = complete response (CR) + partial response (PR) using RECIST. * CR=disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level * PR=at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=9 Participants
* Pemetrexed 500 mg/m\^2 IV over 10 minutes
* Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
* Each cycle will last 21 days.
|
|---|---|
|
Overall Response Rate (ORR)
Complete response
|
0 percentage of participants
|
|
Overall Response Rate (ORR)
Partial response
|
33 percentage of participants
|
SECONDARY outcome
Timeframe: Until patient progresses (median follow-up 293 days -- range (63-632 days)-Progressive disease=at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=9 Participants
* Pemetrexed 500 mg/m\^2 IV over 10 minutes
* Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
* Each cycle will last 21 days.
|
|---|---|
|
Time to Disease Progression
|
3.6 months
Interval 1.1 to 7.4
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Pemetrexed + Carboplatin
n=9 Participants
* Pemetrexed 500 mg/m\^2 IV over 10 minutes
* Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
* Each cycle will last 21 days.
|
|---|---|
|
Overall Survival Rate
|
22.2 percentage of participants
|
SECONDARY outcome
Timeframe: 30 days following completion of treatment (maximum number of cycles = 6)Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=9 Participants
* Pemetrexed 500 mg/m\^2 IV over 10 minutes
* Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
* Each cycle will last 21 days.
|
|---|---|
|
Toxicities
Cardiac ischemia/infarction
|
1 participants
|
|
Toxicities
Pancreatitis
|
1 participants
|
|
Toxicities
Tumor pain
|
1 participants
|
|
Toxicities
Chest/thorax pain
|
1 participants
|
|
Toxicities
Hemoglobin
|
8 participants
|
|
Toxicities
Chest pain
|
1 participants
|
|
Toxicities
Dry eye syndrome
|
1 participants
|
|
Toxicities
Abdominal pain
|
2 participants
|
|
Toxicities
Constipation
|
3 participants
|
|
Toxicities
Diarrhea
|
3 participants
|
|
Toxicities
Dysphagia
|
1 participants
|
|
Toxicities
Hiccoughs
|
1 participants
|
|
Toxicities
Mucositis
|
2 participants
|
|
Toxicities
Nausea
|
6 participants
|
|
Toxicities
Oral cavity pain
|
1 participants
|
|
Toxicities
Stomatitis
|
1 participants
|
|
Toxicities
Vomiting
|
4 participants
|
|
Toxicities
Chills
|
2 participants
|
|
Toxicities
Edema
|
1 participants
|
|
Toxicities
Fatigue
|
5 participants
|
|
Toxicities
Fever
|
1 participants
|
|
Toxicities
Sweating
|
5 participants
|
|
Toxicities
Colitis (c. difficile)
|
1 participants
|
|
Toxicities
Infection without neutropenia
|
1 participants
|
|
Toxicities
ALT
|
4 participants
|
|
Toxicities
AST
|
2 participants
|
|
Toxicities
Alkaline phosphtase
|
2 participants
|
|
Toxicities
Leukocytes (WBC)
|
3 participants
|
|
Toxicities
Low CO2
|
2 participants
|
|
Toxicities
Lymphopenia
|
6 participants
|
|
Toxicities
Neutrophils
|
2 participants
|
|
Toxicities
Platelets
|
1 participants
|
|
Toxicities
Weight loss
|
1 participants
|
|
Toxicities
Anorexia
|
2 participants
|
|
Toxicities
Dehydration
|
1 participants
|
|
Toxicities
Hypercalcemia
|
1 participants
|
|
Toxicities
Hyperglycemia
|
3 participants
|
|
Toxicities
Hyperkalemia
|
3 participants
|
|
Toxicities
Hypernatremia
|
3 participants
|
|
Toxicities
Hypoalbuminemia
|
3 participants
|
|
Toxicities
Hypocalcemia
|
1 participants
|
|
Toxicities
Hypoglycemia
|
1 participants
|
|
Toxicities
Hypokalemia
|
1 participants
|
|
Toxicities
Hyponatremia
|
1 participants
|
|
Toxicities
Lipase
|
1 participants
|
|
Toxicities
Back pain
|
1 participants
|
|
Toxicities
Hernia
|
1 participants
|
|
Toxicities
Limb pain
|
1 participants
|
|
Toxicities
Dizziness
|
3 participants
|
|
Toxicities
Headache
|
3 participants
|
|
Toxicities
Neuropathy - motor
|
1 participants
|
|
Toxicities
Neuropathy - sensory
|
5 participants
|
|
Toxicities
Insomnia
|
4 participants
|
|
Toxicities
Mood alteration - anxiety
|
2 participants
|
|
Toxicities
Creatinine
|
1 participants
|
|
Toxicities
Creatinine clearance
|
1 participants
|
|
Toxicities
Allergic rhintis
|
2 participants
|
|
Toxicities
Cough
|
4 participants
|
|
Toxicities
Dyspnea
|
3 participants
|
|
Toxicities
Hemorrhage - nose
|
1 participants
|
|
Toxicities
Alopecia
|
1 participants
|
|
Toxicities
Dry skin
|
2 participants
|
|
Toxicities
Other: skin
|
1 participants
|
|
Toxicities
Puritis
|
1 participants
|
|
Toxicities
Rash
|
1 participants
|
|
Toxicities
Skin breakdown/decubitous ulcer
|
1 participants
|
|
Toxicities
Hot flash
|
1 participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Pemetrexed + Carboplatin
n=9 Participants
* Pemetrexed 500 mg/m\^2 IV over 10 minutes
* Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
* Each cycle will last 21 days.
|
|---|---|
|
Overall Survival Rate
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Until patient's death (median follow-up 293 days -- range (63-632 days))OS is defined as the time from initiation of treatment to the date of any reason death while those living subjects will be censored at the last assessment date.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=9 Participants
* Pemetrexed 500 mg/m\^2 IV over 10 minutes
* Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
* Each cycle will last 21 days.
|
|---|---|
|
Overall Survival (OS)
|
9.6 months
Interval 2.1 to 17.5
|
Adverse Events
Pemetrexed + Carboplatin
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed + Carboplatin
n=9 participants at risk
* Pemetrexed 500 mg/m\^2 IV over 10 minutes
* Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
* Each cycle will last 21 days.
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Chest/thorax pain
|
11.1%
1/9
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
11.1%
1/9
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
11.1%
1/9
|
Other adverse events
| Measure |
Pemetrexed + Carboplatin
n=9 participants at risk
* Pemetrexed 500 mg/m\^2 IV over 10 minutes
* Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
* Each cycle will last 21 days.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
22.2%
2/9
|
|
General disorders
Chills
|
22.2%
2/9
|
|
General disorders
Edema
|
11.1%
1/9
|
|
General disorders
Fatigue
|
55.6%
5/9
|
|
General disorders
Fever
|
11.1%
1/9
|
|
Vascular disorders
Hot flash
|
11.1%
1/9
|
|
General disorders
Sweating
|
55.6%
5/9
|
|
Investigations
Weight loss
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitous ulcer
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.2%
2/9
|
|
Skin and subcutaneous tissue disorders
Other: skin
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Puritis
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
2/9
|
|
Gastrointestinal disorders
Constipation
|
33.3%
3/9
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
3/9
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9
|
|
Gastrointestinal disorders
Hiccoughs
|
11.1%
1/9
|
|
Gastrointestinal disorders
Mucositis
|
22.2%
2/9
|
|
Gastrointestinal disorders
Nausea
|
66.7%
6/9
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
1/9
|
|
Gastrointestinal disorders
Vomiting
|
44.4%
4/9
|
|
Blood and lymphatic system disorders
Hemoglobin
|
88.9%
8/9
|
|
Investigations
Leukocytes (WBC)
|
33.3%
3/9
|
|
Investigations
Lymphopenia
|
66.7%
6/9
|
|
Investigations
Neutrophils (ANC)
|
22.2%
2/9
|
|
Investigations
Platelets
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage - nose
|
11.1%
1/9
|
|
Infections and infestations
Infection without neutropenia
|
11.1%
1/9
|
|
Infections and infestations
Colitis (c. difficile)
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
3/9
|
|
Investigations
Alkaline phosphatase
|
22.2%
2/9
|
|
Investigations
ALT
|
44.4%
4/9
|
|
Investigations
AST
|
22.2%
2/9
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
1/9
|
|
Investigations
Low CO2
|
22.2%
2/9
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
3/9
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Lipase
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
3/9
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Hypernatremia
|
33.3%
3/9
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
1/9
|
|
Nervous system disorders
Dizziness
|
33.3%
3/9
|
|
Nervous system disorders
Headache
|
33.3%
3/9
|
|
Psychiatric disorders
Insomnia
|
44.4%
4/9
|
|
Psychiatric disorders
Mood alteration - anxiety
|
22.2%
2/9
|
|
Nervous system disorders
Neuropathy - sensory
|
55.6%
5/9
|
|
Nervous system disorders
Neuropathy - motor
|
11.1%
1/9
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
2/9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9
|
|
Cardiac disorders
Chest pain
|
11.1%
1/9
|
|
Gastrointestinal disorders
Oral cavity pain
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Limb pain
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.4%
4/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
3/9
|
|
Renal and urinary disorders
Creatinine
|
11.1%
1/9
|
|
Renal and urinary disorders
Creatinine clearance
|
11.1%
1/9
|
|
Eye disorders
Dry eye syndrome
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
11.1%
1/9
|
Additional Information
Maria Baggstrom, M.D.
Washington University School of Medicine
Phone: 314-362-5740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place