Trial Outcomes & Findings for Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma (NCT NCT00189137)
NCT ID: NCT00189137
Last Updated: 2015-12-07
Results Overview
To contrast the proportion of treated patients hospitalized subsequent to treatment with gemcitabine and docetaxel as compared to doxorubicin and ifosfamide as neoadjuvant or adjuvant therapy of poor prognosis soft tissue sarcoma.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
12 weeks
Results posted on
2015-12-07
Participant Flow
84 patients were enrolled and randomized at the University of Michigan, however 4 patients withdrew consent prior to treatment. 80 patients began study treatment.
Participant milestones
| Measure |
Doxorubicin and Ifosfamide
Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
|
Gemcitabine and Docetaxel
Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
43
|
|
Overall Study
COMPLETED
|
37
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Doxorubicin and Ifosfamide
n=37 Participants
Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
|
Gemcitabine and Docetaxel
n=43 Participants
Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
57 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksTo contrast the proportion of treated patients hospitalized subsequent to treatment with gemcitabine and docetaxel as compared to doxorubicin and ifosfamide as neoadjuvant or adjuvant therapy of poor prognosis soft tissue sarcoma.
Outcome measures
| Measure |
Doxorubicin and Ifosfamide
n=37 Participants
Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
|
Gemcitabine and Docetaxel
n=43 Participants
Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
|
|---|---|---|
|
Percentage of Patients Hospitalized in Each Arm.
|
35 percentage of patients hospitalized
|
26 percentage of patients hospitalized
|
SECONDARY outcome
Timeframe: 2 yearsDisease-free survival
Outcome measures
| Measure |
Doxorubicin and Ifosfamide
n=37 Participants
Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
|
Gemcitabine and Docetaxel
n=43 Participants
Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
|
|---|---|---|
|
The Percentage of Patients Alive Without Disease at 2 Years
|
57 percentage of patients
|
74 percentage of patients
|
Adverse Events
Doxorubicin and Ifosfamide
Serious events: 12 serious events
Other events: 30 other events
Deaths: 0 deaths
Gemcitabine and Docetaxel
Serious events: 12 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doxorubicin and Ifosfamide
n=37 participants at risk
Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
|
Gemcitabine and Docetaxel
n=43 participants at risk
Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Ataxia (incoordination)
|
2.7%
1/37
|
0.00%
0/43
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
2.7%
1/37
|
0.00%
0/43
|
|
Cardiac disorders
Cardiac troponin I (cTnI)
|
2.7%
1/37
|
0.00%
0/43
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37
|
0.00%
0/43
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
2.7%
1/37
|
0.00%
0/43
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.7%
1/37
|
0.00%
0/43
|
|
Gastrointestinal disorders
Esophagitis
|
2.7%
1/37
|
0.00%
0/43
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.2%
6/37
|
0.00%
0/43
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.7%
1/37
|
0.00%
0/43
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
0.00%
0/37
|
9.3%
4/43
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
5.4%
2/37
|
0.00%
0/43
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
2.7%
1/37
|
0.00%
0/43
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
2.7%
1/37
|
0.00%
0/43
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/37
|
2.3%
1/43
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/37
|
2.3%
1/43
|
|
General disorders
Edema: limb
|
0.00%
0/37
|
2.3%
1/43
|
|
General disorders
Fever
|
0.00%
0/37
|
4.7%
2/43
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory
|
0.00%
0/37
|
2.3%
1/43
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37
|
2.3%
1/43
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/37
|
2.3%
1/43
|
Other adverse events
| Measure |
Doxorubicin and Ifosfamide
n=37 participants at risk
Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
|
Gemcitabine and Docetaxel
n=43 participants at risk
Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
|
|---|---|---|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
2.7%
1/37
|
9.3%
4/43
|
|
Musculoskeletal and connective tissue disorders
Ataxia (incoordination)
|
2.7%
1/37
|
0.00%
0/43
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
2.7%
1/37
|
0.00%
0/43
|
|
Cardiac disorders
Cardiac troponin I (cTnI)
|
2.7%
1/37
|
0.00%
0/43
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
2/37
|
0.00%
0/43
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
2.7%
1/37
|
0.00%
0/43
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.7%
1/37
|
0.00%
0/43
|
|
Gastrointestinal disorders
Esophagitis
|
5.4%
2/37
|
0.00%
0/43
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
5.4%
2/37
|
18.6%
8/43
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.2%
6/37
|
0.00%
0/43
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
10.8%
4/37
|
14.0%
6/43
|
|
Blood and lymphatic system disorders
Hemoglobin
|
24.3%
9/37
|
9.3%
4/43
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
0.00%
0/37
|
11.6%
5/43
|
|
Infections and infestations
Infection with unknown ANC
|
2.7%
1/37
|
0.00%
0/43
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
67.6%
25/37
|
16.3%
7/43
|
|
Blood and lymphatic system disorders
Lymphopenia
|
21.6%
8/37
|
11.6%
5/43
|
|
Investigations
Mucositis/stomatitis (clinical exam)
|
2.7%
1/37
|
2.3%
1/43
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
62.2%
23/37
|
16.3%
7/43
|
|
General disorders
Pain
|
2.7%
1/37
|
4.7%
2/43
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
10.8%
4/37
|
0.00%
0/43
|
|
Blood and lymphatic system disorders
Platelets
|
32.4%
12/37
|
14.0%
6/43
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
5.4%
2/37
|
0.00%
0/43
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
8.1%
3/37
|
2.3%
1/43
|
|
Nervous system disorders
Syncope (fainting)
|
2.7%
1/37
|
2.3%
1/43
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/37
|
7.0%
3/43
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/37
|
2.3%
1/43
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/37
|
2.3%
1/43
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/37
|
2.3%
1/43
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/37
|
2.3%
1/43
|
|
General disorders
Edema: limb
|
0.00%
0/37
|
2.3%
1/43
|
|
General disorders
Fever
|
0.00%
0/37
|
4.7%
2/43
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
0.00%
0/37
|
2.3%
1/43
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory
|
0.00%
0/37
|
2.3%
1/43
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils
|
0.00%
0/37
|
2.3%
1/43
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/37
|
7.0%
3/43
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/37
|
4.7%
2/43
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/37
|
2.3%
1/43
|
Additional Information
Dr. Scott Schuetze, M.D., Ph.D.
University of Michigan Comprehensive Cancer Center
Phone: 1-800-865-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place