Choosing to participate in a study is an important personal decision.
Patients must have < grade 2 pre-existing peripheral neuropathy (per CTCAE). Int J Radiat Oncol Biol Phys. Archive
Milgrom SA, Kollmeier MA, Abu-Rustum NR, Tew WP, Sonoda Y, Barakat RR, Alektiar KM. Five-year outcomes of adjuvant carboplatin/paclitaxel chemotherapy and intravaginal radiation for stage I-II papillary serous endometrial cancer. To evaluate the safety of treatment with carboplatin and abraxane in this patient population and determine the nature and degree of toxicities following treatment. (No expression is categorized as ≤ 10% of cells staining or Allred ≤ 2); Eastern Cooperative Oncology Group (ECOG)ECOG/Zubrod performance status of 0 or 1; life expectancy ≥ 3 months; No prior chemotherapy for metastatic disease. Stage III uterine serous carcinoma: modern trends in multimodality treatment. Newest Articles Outcome and patterns of failure in pathologic stages I-IV clear-cell carcinoma of the endometrium: implications for adjuvant radiation therapy. Epub 2018 Oct 2. doi: 10.3802/jgo.2018.29.e49. The proportion of patients experiencing any neurotoxicity will be tabulated by grade. The primary objective of the trial is to statistically test whether Abraxane® and carboplatin can improve progression-free survival (PFS) as compared to historical controls. Treatment with ABRAXANE plus carboplatin may help control or slow the spread of cancer cells. Epub 2020 Jan 14. Clipboard, Search History, and several other advanced features are temporarily unavailable. Known hypersensitivity to any component of any study drug. At 60 months, 59% (95% CI 53%-65%) and 58% (95% CI 53%-64%) of patients were alive, recurrence-free on combined modality and chemotherapy only arms, respectively (hazard ratio was 0.9; 90% CI 0.74 to 1.10). 346 women received the combined modality treatment, which included cisplatin and volume-directed radiation followed by 4 cycles of carboplatin and paclitaxel, over a median of 21 weeks, whereas 361 women received chemotherapy alone in 6 cycles over a median of 17 weeks.
Drugs used in chemotherapy, such as nab-paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Cancer Chemother Pharmacol. JCO OP DAiS, ASCO eLearning Patients receive nab-paclitaxel intravenously (IV) over 30 minutes on days 1 and 8 and carboplatin IV over 3 hours on day 1. Aloisi A, Casanova JM, Tseng JH, Seader KA, Nguyen NT, Alektiar KM, Makker V, Chiang S, Soslow RA, Leitao MM Jr, Abu-Rustum NR. The purpose of this study is to evaluate the safety of treatment with carboplatin and Abraxane in this patient population and determine the nature and degree of toxicities following treatment. Read our, ClinicalTrials.gov Identifier: NCT02744898, Interventional To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Cancer.Net, ASCO.org Conclusions: Abraxane could be used to prevent paclitaxel hypersesitivity reaction HSR.
"This combined modality approach to locally advanced endometrial carcinoma has been previously studied, however, earlier trials never compared the regimen to chemotherapy given alone, stated Daniela Matei, MD, of the Division of Gynecologic Oncology at Northwestern University and the lead author of the NRG-GOG 0258 manuscript. I.
Information provided by (Responsible Party): Taxanes (such as paclitaxel) are highly active to treat breast cancer. Response rate and safety will be assessed. Patients may not have received prior cytotoxic chemotherapy. Combined modality treatment reduced the 5-year incidence of vaginal (2% vs. 7%, HR = 0.36, 95% CI 0.16 to 0.82), pelvic and para-aortic lymph node recurrences compared to chemotherapy alone (11% vs. 20%, HR=0.43, 95% CI 0.28 to 0.66), but distant recurrences were more common with combined modality treatment (27% vs. 21%, HR 1.36, 95% CI 1 to 1.86). 2020 Mar;14(3):645-656. doi: 10.1002/1878-0261.12627. Patients must have a GOG performance status of 0, 1, or 2. The New England Journal of Medicine recently published the primary endpoint of the NRG Oncology clinical trial NRG-GOG 0258, which showed that carboplatin and paclitaxel chemotherapy preceded by radiotherapy with concurrent cisplatin, or combined modality therapy, did not significantly increase recurrence-free survival for women with stage 3-4A endometrial cancer when compared to … Int J Environ Res Public Health. Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI), unstable angina, stroke, or transient ischemia within previous 6 months.
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Vaginal brachytherapy alone is sufficient adjuvant treatment of surgical stage I endometrial cancer. 2020 Aug 16;17(16):5941. doi: 10.3390/ijerph17165941. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Young MR(1), Higgins SA, Ratner E, Yu JB, Mani S, Silasi DA, Azodi M, Rutherford T, Schwartz PE, Damast S. The proportion of patients experiencing ≥ grade 3 non-hematologic toxicities (excluding neurotoxicity) and the proportion of patients experiencing ≥ grade 3 hematologic toxicities will be calculated with their exact 80% confidence intervals. Stay up to date with our ecancer newsletter, Explore patient resources at ecancerpatient, Find out more about ecancer and the work we do, Support ecancer's work by making a donation, The content on this site is intended for healthcare professionals only, ESMO 2020: KRAS inhibitor sotorasib appears safe, achieves durable clinical benefit in early trial, Researchers now better understand ovarian cancer tumours and treatment outcomes, Researchers discover how enzyme protects cells from DNA damage, A new way to target cancers using 'synthetic lethality', ASCO 2020: Adoptive T-cell therapy ADP-A2M4 targeting MAGE-A4 shows early activity in patients with advanced solid tumours, ASCO 2020: Immunotherapy avelumab shows potential in rare gynaecological cancer resistant to chemotherapy, New targeted agent produces considerable responses in patients with uterine cancer, Drug overcomes chemotherapy resistance in ovarian cancer, FDA approves mitomycin for low-grade upper tract urothelial cancer, Therapeutic HPV vaccine may improve outcomes in advanced cervical cancer. Taxanes (such as paclitaxel) are highly active to treat breast cancer. Gynecol Oncol. Get the latest public health information from CDC: https://www.coronavirus.gov. ASCO Connection To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The single stage open label Phase II feasibility study is designed to estimate the proportion of patients who can tolerate the proposed regimen for 6 cycles with no more than two dose level reductions. Prior chemotherapy for metastatic breast cancer. 2001 Oct 15. Recently, prospective trials have shown that paclitaxel may be the most active agent in the treatment of endometrial After completion of study treatment, patients are followed up at 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months. CancerLinQ Epub 2009 Jul 25. need. May 20, 2008. COVID-19 is an emerging, rapidly evolving situation. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Read our, ClinicalTrials.gov Identifier: NCT01207102, Interventional Perrone E, Manara P, Lopez S, Bellone S, Bonazzoli E, Manzano A, Zammataro L, Bianchi A, Zeybek B, Buza N, Tymon-Rosario J, Altwerger G, Han C, Menderes G, Huang GS, Ratner E, Silasi DA, Azodi M, Hui P, Schwartz PE, Scambia G, Santin AD. Listing a study does not mean it has been evaluated by the U.S. Federal Government. (Clinical Trial), A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus, Experimental: Carboplatin AUC and Abraxane 100mg/m2, 18 Years and older (Adult, Older Adult). Why Should I Register and Submit Results? National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. Why Should I Register and Submit Results? 2009 Oct;115(1):6-11. doi: 10.1016/j.ygyno.2009.06.035. Study Protocol and Statistical Analysis Plan, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Enter words / phrases / DOI / ISBN / authors / keywords / etc. HHS As cytotoxins, they have been studied alone and in combination with other chemotherapeutic agents, and have been incorporated into treatment regimens for women who fail previous anthracycline-based therapies. Franco M. Muggia, Chat with us: LiveHelp Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/. Epub 2013 Jun 22. DFS (A and C) and OS (B and D) comparing Type I vs…, NLM No hypersensitivity reaction was reported.
To determine objective response rates by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (in patients with measurable disease) at the above time points. | Talk with your doctor and family members or friends about deciding to join a study. Permissions, Authors This multicenter, randomized phase II trial compared carboplatin-paclitaxel with and without trastuzumab in patients … If vaginal brachytherapy is planned with chemotherapy, it should be done before or after completion of chemotherapy treatment. Adjuvant carboplatin, paclitaxel, and vaginal cuff brachytherapy for stage III endometrial cancer: analysis of outcomes and patterns of recurrence based on pathologic characteristics. I. 2020 Jul;31(4):e53. This study was designed to evaluate the efficacy and safety of Abraxane for the treatment of recurrent ovarian cancer. Tolerability for an individual patient will be defined as remaining on the study for 6 cycles with two or fewer dose reductions. For general information, Learn About Clinical Studies. Get the latest research from NIH: https://www.nih.gov/coronavirus. You are encouraged to report negative side effects of prescription drugs to the FDA.
While the primary endpoint was to determine if the combined modality arm increased recurrence-free survival, patients were also observed for secondary endpoints that included overall survival, acute and chronic toxicities, and quality of life. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Klopp AH, Jhingran A, Ramondetta L, Lu K, Gershenson DM, Eifel PJ. Grade 3-5 adverse events were reported in 202 (58%) and 227 (63%) patients in the combined modality and chemotherapy alone arm, respectively. 2012 Nov;127(2):321-5. doi: 10.1016/j.ygyno.2012.07.112. As second-generation compounds, Abraxane® and carboplatin have been shown to improve response rates and may mediate some of the toxicities associated with paclitaxel and cisplatin, respectively. J Clin Oncol. 26, no. Mol Oncol. Paclitaxel and carboplatin, alone or with irradiation, in advanced or recurrent endometrial cancer: a phase II study. Conclusions: Patients may have synchronous endometrial and ovarian cancer primaries. Eligibility to a higher priority trial for first line or recurrent endometrial cancer (unless patient is unwilling to participate in such a trial). When combined with a taxane, platinum agents improve response in metastatic breast cancer, with carboplatin conferring less toxicity than cisplatin.
Postoperative external beam radiation therapy and concurrent cisplatin followed by carboplatin/paclitaxel for stage III (FIGO 2009) endometrial cancer. Response rate and safety will be …
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