Phase II Trial of Oral Rubitecan in Previously Treated Pancreatic Cancer Patients

Burris, Howard A.; Rivkin, Saul E.; Reynolds, Robert E.; Harris, Jules E.; Wax, Arnold; Gerstein, Hal; Mettinger, K.L.; Staddon, Arthur P.

doi:10.1634/theoncologist.10-3-183

Cited by 60 publications

(12 citation statements)

References 18 publications

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“…The present study reports the findings on a single center cohort of patients who received second-line gemcitabine treatment for advanced-stage pancreatic adenocarcinoma. A survival of 3.6 months with second-line chemotherapy was observed, which is in agreement with previous published data (Table I) (7)(8)(9)(10)14,15,(22)(23)(24)(25)(26)(27)(28)(29)(30)(31). Response to gemcitabine therapy at the first follow-up evaluation (at 2 months) impacted significantly the OS of the patients.…”

Section: Discussionsupporting

confidence: 92%

Use of gemcitabine as a second-line treatment following chemotherapy with folfirinox for metastatic pancreatic adenocarcinoma

et al. 2017

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Abstract. There is a lack of prospective data about second-line treatments for metastatic pancreatic ductal adenocarcinoma patients. This is partially due to recent changes in first-line chemotherapy treatments. Despite this dearth of information, 50.0% of the patients who experience failure with first-line folinic acid, 5-fluorouracil, irinotecan and oxaliplatin (folfirinox) treatment are eligible for additional chemotherapy.

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Section: Discussionsupporting

confidence: 92%

Use of gemcitabine as a second-line treatment following chemotherapy with folfirinox for metastatic pancreatic adenocarcinoma

et al. 2017

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“…One co-operative group trial reported that only 45% of patients with APC went on to receive additional therapy following progression on front-line study treatment (Schrag et al , 2007). A number of small prospective single-arm studies have evaluated both cytotoxic and/or targeted agents in the setting of gemcitabine-refractory disease, generally demonstrating low response rates and progression-free survival of a few months at best (Burris et al , 2005; Boeck et al , 2007; Kulke et al , 2007; Ko et al , 2008, 2010; Oh et al , 2010; O'Reilly et al , 2010). Results from a randomised German trial for the second-line treatment of APC (CONKO-003) suggested a weekly regimen called OFF (oxaliplatin, 5-FU given as a 24-hour infusion, and folinic acid) may improve patient outcomes in patients refractory to gemcitabine (Pelzer et al , 2008, 2011).…”

mentioning

confidence: 99%

A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer

et al. 2013

Br J Cancer

146

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Background:PEP02, also known as MM-398, is a novel nanoliposomal irinotecan that has improved pharmacokinetics and tumour bio-distribution of the free drug. This phase 2 study evaluated PEP02 monotherapy as second-line treatment for pancreatic cancer.Methods:Patients who had metastatic pancreatic adenocarcinoma, Karnofsky performance status ⩾70, and had progressed following gemcitabine-based therapy were eligible. Intravenous injection of PEP02 120 mg m−2 was given every 3 weeks. Simon 2-stage design was used. The primary objective was 3-month survival rate (OS3-month).Results:A total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients (7.5%) achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had a >50% biomarker decline. The study met its primary end point with an OS3-month of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively.Conclusion:PEP02 demonstrates moderate antitumour activity with a manageable side effect profile for metastatic, gemcitabine-refractory pancreatic cancer patients. Given the limited treatment options available to this patient population, a phase 3 trial of PEP02 (MM-398), referred to as NAPOLI-1, is currently underway.

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“…Salvage treatment with a single agent, like pemetrexed [32], rubitecan [33], raltitrexed [34], epirubicin [35], capecitabine [36], docetaxel [37] and paclitaxel [38], yielded a median survival of 3.5–4.6 months and a 1-year OS of 0–15%. Apparently better results were reported with combination chemotherapy at time of salvage, with median survival times ranging between 5.2 and 8.3 months and 1-year OS between 12 and 32% [6,7,26,39,40,41,42,43].…”

Section: Discussionmentioning

confidence: 99%

Salvage Therapy with Mitomycin and Ifosfamide in Patients with Gemcitabine-Resistant Metastatic Pancreatic Cancer: A Phase II Trial

Cereda¹,

Reni²,

Rognone³

et al. 2011

Chemotherapy

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Background: At the time of upfront treatment failure, over half of the patients with advanced pancreatic cancer are candidates for further treatment. Methods: Patients with metastatic gemcitabine-resistant pancreatic cancer were treated with mitomycin 8 mg/m² on day 1, ifosfamide 2,500 mg/m² and mesna 3,000 mg/m² on days 1–3 every 28 days until progressive disease. A positive responder was defined as a patient who was progression free at 6 months from trial enrolment. According to the Fleming design, a sample size of 34 patients was estimated assuming p0 = 0.05 and p1 = 0.20. Results: Between May 2006 and December 2007, 21 patients (median age 56 years; median Karnofsky performance score 80) were enrolled. One patient died before receiving any treatment. Eighteen patients interrupted chemotherapy due to progressive disease (n = 15), toxicity (n = 2) or refusal (n = 1). Grade >2 toxicity consisted of neutropenia in 80% of patients, thrombocytopenia and fatigue in 20% and anemia in 10%. Only 1 patient was progression free at 6 months (5%). One patient had a partial response (5%) and 2 patients had stable disease (10%). Median survival was 3.7 months. Conclusion: Based on the poor outcome observed and on the high level of grade 3–4 toxicity, the trial was prematurely stopped and the mitomycin and ifosfamide regimen was considered insufficiently active in gemcitabine-pretreated advanced pancreatic cancer.

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Phase II Trial of Oral Rubitecan in Previously Treated Pancreatic Cancer Patients

Abstract: ABSTRACT

Cited by 60 publications

References 18 publications

Use of gemcitabine as a second-line treatment following chemotherapy with folfirinox for metastatic pancreatic adenocarcinoma

Use of gemcitabine as a second-line treatment following chemotherapy with folfirinox for metastatic pancreatic adenocarcinoma

A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer

Salvage Therapy with Mitomycin and Ifosfamide in Patients with Gemcitabine-Resistant Metastatic Pancreatic Cancer: A Phase II Trial

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