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Radiation Therapy, Pemetrexed Disodium, and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00268437
Recruitment Status : Terminated (Trial closed early because, during an interim analysis, the primary endpoint fell short.)
First Posted : December 22, 2005
Results First Posted : March 27, 2015
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Esophageal Cancer
Interventions Drug: carboplatin
Drug: Pemetrexed
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Enrollment 27
Recruitment Details This trial closed early because, during an interim analysis, the primary endpoint fell short. However, 26 eligible patients were accrued. Due to early closure not all the endpoints were analyzed.
Pre-assignment Details  
Arm/Group Title Pemetrexed/Carboplatin
Hide Arm/Group Description

Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).

Conventional surgery

Period Title: Overall Study
Started 27
Completed 26
Not Completed 1
Reason Not Completed
Ineligible             1
Arm/Group Title Pemetrexed/Carboplatin
Hide Arm/Group Description

Pemetrexed+Carboplatin+Radiation>

> carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.>

> Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.>

> conventional surgery>

> neoadjuvant therapy>

> radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants
66
(42 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
7
  25.9%
Male
20
  74.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title Pathologic Complete Response Rate
Hide Description The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.
Time Frame Baseline to time of surgery (around 10 - 18 weeks post-baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed/Carboplatin
Hide Arm/Group Description:

Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).

conventional surgery

Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23
(9 to 44)
2.Secondary Outcome
Title Overall Survival
Hide Description Time from registration to death due to any cause.
Time Frame From baseline to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed/Carboplatin
Hide Arm/Group Description:

Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).

Conventional surgery

Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: months
17.8
(12.2 to 30.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed/Carboplatin
Hide Arm/Group Description

Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).

Conventional surgery

All-Cause Mortality
Pemetrexed/Carboplatin
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Pemetrexed/Carboplatin
Affected / at Risk (%) # Events
Total   6/27 (22.22%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  1/27 (3.70%)  1
Cardiac disorders   
Atrial fibrillation  1  1/27 (3.70%)  1
Gastrointestinal disorders   
Dysphagia  1  1/27 (3.70%)  1
Esophageal fistula  1  1/27 (3.70%)  1
Nausea  1  1/27 (3.70%)  1
Small intestinal obstruction  1  1/27 (3.70%)  1
Vomiting  1  1/27 (3.70%)  1
Infections and infestations   
Sepsis  1  1/27 (3.70%)  1
Investigations   
Leukocyte count decreased  1  1/27 (3.70%)  1
Neutrophil count decreased  1  1/27 (3.70%)  1
Platelet count decreased  1  1/27 (3.70%)  1
Metabolism and nutrition disorders   
Serum phosphate decreased  1  1/27 (3.70%)  1
Serum potassium decreased  1  1/27 (3.70%)  1
Renal and urinary disorders   
Renal failure  1  1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome  1  1/27 (3.70%)  1
Dyspnea  1  1/27 (3.70%)  1
Pneumonitis  1  1/27 (3.70%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pemetrexed/Carboplatin
Affected / at Risk (%) # Events
Total   27/27 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  25/27 (92.59%)  59
Cardiac disorders   
Atrial fibrillation  1  2/27 (7.41%)  2
Myocardial ischemia  1  1/27 (3.70%)  1
Pericardial effusion  1  1/27 (3.70%)  1
Pericarditis  1  1/27 (3.70%)  1
Gastrointestinal disorders   
Constipation  1  3/27 (11.11%)  4
Diarrhea  1  11/27 (40.74%)  15
Dysphagia  1  20/27 (74.07%)  48
Esophageal mucositis  1  7/27 (25.93%)  10
Esophageal pain  1  11/27 (40.74%)  21
Esophagitis  1  16/27 (59.26%)  30
Nausea  1  19/27 (70.37%)  36
Oesophagoscopy abnormal  1  7/27 (25.93%)  9
Vomiting  1  9/27 (33.33%)  12
General disorders   
Death NOS  1  1/27 (3.70%)  1
Edema limbs  1  1/27 (3.70%)  1
Fatigue  1  8/27 (29.63%)  12
Infections and infestations   
Endocarditis infective  1  1/27 (3.70%)  1
Pharyngitis  1  1/27 (3.70%)  1
Pleural infection  1  2/27 (7.41%)  2
Pneumonia  1  2/27 (7.41%)  2
Small intestine infection  1  1/27 (3.70%)  1
Soft tissue infection  1  1/27 (3.70%)  1
Upper respiratory infection  1  1/27 (3.70%)  1
Urinary tract infection  1  1/27 (3.70%)  1
Wound infection  1  1/27 (3.70%)  1
Injury, poisoning and procedural complications   
Esophageal anastomotic leak  1  1/27 (3.70%)  1
Vascular access complication  1  1/27 (3.70%)  1
Investigations   
Alkaline phosphatase increased  1  1/27 (3.70%)  2
Aspartate aminotransferase increased  1  8/27 (29.63%)  9
Blood bilirubin increased  1  1/27 (3.70%)  1
Leukocyte count decreased  1  24/27 (88.89%)  43
Lymphocyte count decreased  1  1/27 (3.70%)  2
Neutrophil count decreased  1  23/27 (85.19%)  37
Platelet count decreased  1  23/27 (85.19%)  47
Weight loss  1  2/27 (7.41%)  5
Metabolism and nutrition disorders   
Anorexia  1  4/27 (14.81%)  8
Blood glucose increased  1  1/27 (3.70%)  1
Dehydration  1  2/27 (7.41%)  3
Serum albumin decreased  1  1/27 (3.70%)  1
Serum glucose decreased  1  1/27 (3.70%)  1
Serum phosphate decreased  1  1/27 (3.70%)  1
Serum potassium decreased  1  1/27 (3.70%)  1
Musculoskeletal and connective tissue disorders   
Chest wall pain  1  1/27 (3.70%)  1
Muscle weakness  1  1/27 (3.70%)  1
Neck pain  1  1/27 (3.70%)  2
Nervous system disorders   
Dysgeusia  1  1/27 (3.70%)  1
Headache  1  1/27 (3.70%)  1
Peripheral sensory neuropathy  1  3/27 (11.11%)  8
Psychiatric disorders   
Depression  1  5/27 (18.52%)  5
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome  1  2/27 (7.41%)  2
Aspiration  1  1/27 (3.70%)  1
Atelectasis  1  1/27 (3.70%)  1
Cough  1  1/27 (3.70%)  1
Dyspnea  1  8/27 (29.63%)  14
Hiccups  1  1/27 (3.70%)  1
Hypoxia  1  2/27 (7.41%)  3
Pleural effusion  1  3/27 (11.11%)  3
Pneumonitis  1  1/27 (3.70%)  1
Pneumothorax  1  2/27 (7.41%)  2
Skin and subcutaneous tissue disorders   
Decubitus ulcer  1  1/27 (3.70%)  1
Erythema multiforme  1  1/27 (3.70%)  1
Rash acneiform  1  1/27 (3.70%)  1
Rash desquamating  1  10/27 (37.04%)  12
Vascular disorders   
Hypotension  1  7/27 (25.93%)  10
Thrombosis  1  2/27 (7.41%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aminah Jatoi, M.D.
Organization: Mayo Clinic
Phone: 507/284-4918
EMail: jatoi.aminah@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00268437    
Other Study ID Numbers: NCCTG-N044E
NCI-2012-02678 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000455635 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: December 20, 2005
First Posted: December 22, 2005
Results First Submitted: March 9, 2015
Results First Posted: March 27, 2015
Last Update Posted: July 6, 2016