See Contacts and Locations. Study Description. This is an open-label, non-randomized, single-institution, single arm Phase II study conducted using a Simon two-stage design with an additional safety lead-in.
Detailed Description:. The sample size calculation is based on a Simon Two-Stage design with incorporation of early stopping rules for safety and futility See section 9 for statistical considerations. The Investigators will enroll up to 35 patients on the study to obtain 28 evaluable patients for the primary endpoint. Safety of the combination will be evaluated after the first six patients complete the DLT observation period of 9 weeks.
This lengthy DLT period is designed to capture safety and toxicity profile, understanding that immune-related toxicities from checkpoint inhibitors may not emerge immediately. This will also ensure adequate evaluation of potential cardiac and hepatic toxicity from combination doxorubicin and checkpoint inhibitor therapy. If two or more patients experience DLT in the initial safety lead-in cohort, the regimen will be declared intolerable. Any patients who do not complete study therapy through the 9-week DLT observation period for any reasons other than toxicity will be replaced for safety lead-in assessment.
If fewer than two patients experience DLT, the investigators will proceed to expansion to complete enrollment of 15 patients in Stage 1. Following enrollment of stage one, accrual will pause for analysis of efficacy.
If 6 or fewer of the 15 patients are progression-free at 6 months, the investigators will halt the study for futility. If 7 or more patients are free from progression, then the investigators will proceed with enrollment of 13 additional patients to complete stage 2. Drug Information available for: Doxorubicin Doxorubicin hydrochloride. FDA Resources. Arms and Interventions. Outcome Measures.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Provision to sign and date the consent form. Stated willingness to comply with all study procedures and be available for the duration of the study.
Be male or female aged years at the time of signing informed consent. Have a histological diagnosis of advanced or metastatic soft tissue sarcoma STS by local pathology review , not curable by surgery, for which treatment with doxorubicin is deemed appropriate by the investigator. Global Cancer Research. Cancer Research Infrastructure. Clinical Trials. Frederick National Laboratory for Cancer Research. Bioinformatics, Big Data, and Cancer.
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Social Media Events. Cancer Currents Blog. Contributing to Cancer Research. Clinical Cancer Research. Phase II study of pegylated liposomal doxorubicin in heavily pretreated epithelial ovarian cancer patients: may a new treatment schedule improve toxicity profile? Cancer Chemotherapy and Pharmacology. Phase II study of pegylated liposomal doxorubicin and carboplatin in patients with platinum-sensitive and partially platinum-sensitive metastatic ovarian cancer.
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Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer.
Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. Phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in progressive or recurrent ovarian cancer. Single agent carboplatin versus carboplatin plus pegylated liposomal doxorubicin in recurrent ovarian cancer: final survival results of a SWOG S phase 3 randomized trial.
Pegylated liposomal doxorubicin and carboplatin compared with paclitaxel and carboplatin for patients with platinum-sensitive ovarian cancer in late relapse. A phase II clinical trial of pegylated liposomal doxorubicin and carboplatin plus bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer.
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Archives of Dermatology. Gabizon AA. Liposomal anthracyclines. Risk factors for doxorubicin-induced congestive heart failure. Annals of Internal Medicine. Reduced cardiotoxicity and preserved antitumor efficacy of liposome-encapsulated doxorubicin and cyclophosphamide compared with conventional doxorubicin and cyclophosphamide in a randomized, multicenter trial of metastatic breast cancer. Mustafa MH. Biweekly pegylated liposomal doxorubicin as second-line treatment in patients with relapsed ovarian cancer after failure of platinum and paclitaxel: results from a multi-center phase II study of the NOGGO.
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Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive platinum-free interval 6—12 months subpopulation of OVA phase III randomized trial. Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients: results from a subset analysis of the CALYPSO phase III trial. Optimal therapy of advanced ovarian cancer: carboplatin and paclitaxel vs.
Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: the MITO-2 randomized phase III trial. Pegylated liposomal doxorubicin PLD with bevacizumab B in second-line treatment of ovarian cancer OC : pharmacokinetics PK , safety, and preliminary outcome results.
Foulkes WD. Familial Cancer. Phase II, open-label, randomized, multicenter study comparing the efficacy and safety of olaparib, a poly ADP-ribose polymerase inhibitor, and pegylated liposomal doxorubicin in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer.
A high response rate to liposomal doxorubicin is seen among women with BRCA mutations treated for recurrent epithelial ovarian cancer. BRCA mutation status and determinant of outcome in women with recurrent epithelial ovarian cancer treated with pegylated liposomal doxorubicin.
Molecular Cancer Therapeutics. Support Center Support Center. External link. Please review our privacy policy. Muggia et al. Gordon et al. Rose et al. Katsumata et al. Lorusso et al. Sehouli et al. Du Bois et al. Rapoport et al. Ferrero et al. D'Agostino et al. The purpose of the safety lead-in phase is to establish a safe and tolerable dose combination "the recommended dose" which will be used during the remainder of the study. Evaluation of Side Effects from APXO05M and Doxorubicin Treatment [ Time Frame: 18 months ] Patients on the study will be assessed at regular intervals during clinical visits and through laboratory testing to monitor side effects from the study treatment.
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Histologically confirmed advanced soft tissue sarcoma for which doxorubicin treatment is considered appropriate.
Patients with well-differentiated liposarcoma who have histologic evidence of a dedifferentiated component are eligible. Kaposi sarcoma and gastrointestinal stromal tumor GIST are not eligible. Protocol Amendment 4 restricts further enrollment to participants with the following sarcoma subtypes.
A total of 10 patients will be enrolled with each of the following sarcoma subtypes for the entire study, inclusive of patients enrolled prior to Amendment Patients may not have history of another primary cancer, with the exception of:. Try the modernized ClinicalTrials. Learn more about the modernization effort.
Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies APXM and Doxorubicin in Advanced Sarcoma The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
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