절제 불가능 또는 전이성 연조직 육종에서 Palifosfamide Tris + Doxorubicin과 Doxorubicin 비교 연구 (PICASSO)
절제 불가능하거나 전이성 연조직 육종이 있는 피험자에서 Palifosfamide Tris + Doxorubicin 대 Doxorubicin의 II상 다기관, 병렬 그룹, 무작위 연구
This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS). Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will be anthracyclin naïve.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Cluj-Napoca, 루마니아, 400015
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Lasi, 루마니아
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California
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Santa Monica, California, 미국
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District of Columbia
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Washington D.C., District of Columbia, 미국
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Florida
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Tampa, Florida, 미국
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Idaho
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Coeur d'Alene, Idaho, 미국, 83814
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Illinois
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Chicago, Illinois, 미국
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Park Ridge, Illinois, 미국
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Iowa
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Iowa City, Iowa, 미국
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Kansas
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Lenexa, Kansas, 미국
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New Mexico
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Albuquerque, New Mexico, 미국
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New York
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New York, New York, 미국
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North Carolina
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Durham, North Carolina, 미국
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Oregon
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Portland, Oregon, 미국
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Pennsylvania
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Philadelphia, Pennsylvania, 미국
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Tennessee
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Memphis, Tennessee, 미국
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Nashville, Tennessee, 미국
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Texas
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San Antonio, Texas, 미국
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Utah
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Salt Lake City, Utah, 미국
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Washington
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Seattle, Washington, 미국
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Milan, 이탈리아
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Padova, 이탈리아
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Torino, 이탈리아
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Age ≥18 years
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Histological or cytological documentation of sarcoma (excluding alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma) who have failed ≤2 prior regimens including adjuvant therapy, or ≤1 prior regimen for metastatic/unresectable disease, and for whom treatment with doxorubicin is considered medically acceptable. Prior treatment with IFOS is acceptable.
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Have measurable disease as per RECIST criteria (Appendix 2)
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ECOG Performance Status of 0 or 1 (Appendix 3)
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Anthracyclin naïve
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Life expectancy of ≥12 weeks
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Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements conducted within 14 days prior to dosing:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1,500/mm3
- Platelet count 100,000/mm3
- Total bilirubin ≤1.5×ULN (upper limit of normal)
- ALT and AST ≤2.5×ULN or 5×ULN with hepatic disease
- Partial thromboplastin [PT]-INR/activated partial thromboplastin time [PTT] <1.5×ULN (≤2.0×ULN for subjects on anticoagulation prophylactic regimen). Subjects who are being therapeutically anticoagulated with an agent such as Coumadin (warfarin sodium) or heparin are allowed provided there is no prior evidence of underlying abnormality in coagulation parameters. If an interaction between study drug and anticoagulant is suspected, anticoagulation monitoring should be increased as appropriate.
- Serum creatinine ≤ULN
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Written informed consent must be obtained from a potential subject prior to the conduct of any study-specific procedures
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Male and female subjects must agree to use adequate birth control measures/barrier control during the course of the trial
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Women of childbearing potential must have a urine pregnancy test performed within 14 days of the start of treatment
Exclusion Criteria:
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Has any one of the following sarcoma sub types: alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma.
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Clinically evident congestive heart failure >Class II of the New York Heart Association (NYHA) guidelines (Appendix 4)
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Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V (Appendix 4)
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History and/or signs of active coronary artery disease/ischemia with or without angina pectoris
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Serious myocardial dysfunction defined as scintigraphically (MUGA [multiple gated acquisition scan], myocardial scintigram) or ultrasound-determined absolute left ventricular ejection fraction (LVEF) <45%
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History of HIV infection
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Prior nephrectomy or history of urinary tract obstruction
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Active, clinically serious infection requiring systemic antibacterial, antifungal, or antiviral therapy
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Any major surgery within 3 weeks prior to start of treatment
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Metastatic brain or meningeal tumors, unless the subject is >6 months from definitive therapy and has a negative imaging study within 4 weeks of study entry. In addition, the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable, provided the dose is stable for 1 month prior to study start, and following screening radiographic studies).
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Previous malignancy (except cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis, & T1] or other malignancies curatively treated >5 years prior to entry)
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Pregnancy or lactation
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Substance abuse or medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
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Any condition that is unstable or could jeopardize the safety of a subject and his/her compliance with the protocol requirements
In addition, use of the following therapies and medications-prior or concomitant-would exclude a subject from this study:
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Anticancer chemotherapy, immunotherapy, or any investigational drug therapy during the study or within 4 weeks of study entry (6 weeks for Mitomycin C)
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Prior treatment with doxorubicin
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Radiotherapy within 4 weeks of study entry (palliative radiation to bone lesions is permitted if started or planned prior to Cycle 1, Day 1)
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Bone marrow transplant or stem cell rescue within 4 months of study entry
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Growth factors such as G-CSF (granulocyte colony-stimulating factor/filgrastim), or biological response modifiers within 3 weeks of study entry
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Palifosfamide-Tris Plus Doxorubicin
Participants received palifosfamide-tris 150 mg/m² IV on Days 1, 2, and 3 plus doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Doxorubicin was administered approximately 60 minutes after completion of the Day 1 palifosfamide-tris infusion. Participants could continue single-agent palifosfamide-tris after completion of combination treatment. |
Palifosfamide-tris 150 mg/m² administered intravenously on Days 1, 2, and 3 of each 21-day cycle.
다른 이름들:
Doxorubicin 75 mg/m² administered intravenously on Day 1 of each 21-day cycle for up to 6 cycles.
다른 이름들:
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활성 비교기: Doxorubicin Alone With Optional Palifosfamide-Tris After Progression
Participants received doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Participants whose disease progressed at or before Cycle 6 could elect to receive single-agent palifosfamide-tris after disease progression. This treatment was optional and was not part of the randomized initial treatment assignment. |
Palifosfamide-tris 150 mg/m² administered intravenously on Days 1, 2, and 3 of each 21-day cycle.
다른 이름들:
Doxorubicin 75 mg/m² administered intravenously on Day 1 of each 21-day cycle for up to 6 cycles.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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1차 효능 분석은 ITT(intent-to-treat) 집단에 대해 수행될 것이다. 질병이 진행되거나 오프 프로토콜 항암 요법을 시작할 때까지 6주마다 질병 상태 평가를 수행하기 위한 모든 시도가 이루어질 것입니다.
기간: 진행될 때까지 6주마다
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진행될 때까지 6주마다
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공동 작업자 및 조사자
수사관
- 연구 책임자: Jonathan J Lewis, MD, PhD, ZIOPHARM Oncology, Inc
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IPM2002
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