Sarcoma, Soft Tissue
Conditions
Brief summary
The purpose of this study is to explore how a sarcoma is affected by and the side effects of a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.
Detailed description
The purpose of this study is to explore the relative activity and toxicity of a newer combination of chemotherapy drugs, gemcitabine and docetaxel, as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin. Ifosfamide and Doxorubicin, given in combination, are recognized as a standard of care for some types of sarcoma. Both gemcitabine and docetaxel are approved by the US Food and Drug Administration (FDA) for the treatment of some cancers (cancers of the pancreas, lung) because patients with those cancers treated with either gemcitabine or docetaxel experienced shrinkage of their tumor or improvement in their symptoms. However, neither gemcitabine or docetaxel is approved for sarcoma, but the combination of gemcitabine and docetaxel is a standard treatment for advanced sarcoma.
Interventions
DRUGifosfamide and doxorubicin vs gemcitabine and docetaxel
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. 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.
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* no evidence of metastasis * soft tissue sarcoma * intermediate or high histologic grade * greater than 5 cm * Zubrod performance status 1 or better * age 10 or older
Exclusion criteria
* clear cell, alveolar soft part, Ewing's rhabdosarcoma, undifferentiated small cell or Kaposi's * prior chemotherapy * nephrectomy * active unstable angina pectoris * concurrent therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Hospitalized in Each Arm. | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Patients Alive Without Disease at 2 Years | 2 years | Disease-free survival |
Countries
United States
Participant flow
Recruitment details
84 patients were enrolled and randomized at the University of Michigan, however 4 patients withdrew consent prior to treatment. 80 patients began study treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 37 |
| 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. | 43 |
| Total | 80 |
Baseline characteristics
| Characteristic | Doxorubicin and Ifosfamide | Gemcitabine and Docetaxel | Total |
|---|---|---|---|
| Age, Continuous | 55 years | 57 years | 56 years |
| Sex: Female, Male Female | 15 Participants | 12 Participants | 27 Participants |
| Sex: Female, Male Male | 22 Participants | 31 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 37 | 33 / 43 |
| serious Total, serious adverse events | 12 / 37 | 12 / 43 |
Outcome results
Primary
Percentage of Patients Hospitalized in Each Arm.
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.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxorubicin and Ifosfamide | Percentage of Patients Hospitalized in Each Arm. | 35 percentage of patients hospitalized |
| Gemcitabine and Docetaxel | Percentage of Patients Hospitalized in Each Arm. | 26 percentage of patients hospitalized |
Secondary
The Percentage of Patients Alive Without Disease at 2 Years
Disease-free survival
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxorubicin and Ifosfamide | The Percentage of Patients Alive Without Disease at 2 Years | 57 percentage of patients |
| Gemcitabine and Docetaxel | The Percentage of Patients Alive Without Disease at 2 Years | 74 percentage of patients |