Multicenter randomized phase II trial of 5-fluorouracil/leucovorin (5-FU/LV) with or without liposomal irinotecan (nal-IRI) in metastatic biliary tract cancer (BTC) as second-line therapy after progression on gemcitabine plus cisplatin (GemCis): NIFTY trial

e14637 Background: Patients whocannot be offered curative surgical treatment for biliary tract cancer (BTC) have a poor prognosis. Photodynamic therapy (PDT) has been shown to improve survival and quality of life in patients with unresectable BTC. A combination of treatment modalities might improve survival further, but such data are still lacking. Therefore we have performed the first randomized trial on the combination of temoporfin/PDT and chemotherapy. Here we report data on the feasibility and safety. Methods: Randomized phase II trial, planned to include 20 patients with time to progression as primary endpoint, feasibility and toxicity as secondary endpoints. Inclusion criteria were unresectable BTC confirmed by histology or cytology, need for biliary stent, bilirubin level < 50 mmol/L and no previous cancer disease. The treatment arms were: A: Stent, temoporfin / PDT followed by gemcitabin / capecitabin (GemCap). B: Stent, GemCap. Only one initial PDT treatment was given. Results: Twenty patients with locally advanced and metastatic disease were included, 10 patients in each arm. Two patients in arm B did not receive any treatment (thrombocytopenia, study withdrawal) and two patients in arm A did not receive chemotherapy (ECOG>2, infection). PDT was feasible in all 10 patients without any acute procedure-related complication. During the first 30 days, two cases of cholangitis in arm A and three in arm B were observed. Cutaneous erythema (grade 1-2) was observed after PDT in two patients. Conclusions: PDT using temoporfin in combination with chemotherapy in BTC was feasible. Restrictions to light exposure were well tolerated. PDT in combination with chemotherapy did not increase the complication rate during the first 30 days follow-up. Three months follow-up data will be available at the time for presentation. Larger prospective trials are warranted to assess the efficacy of this treatment combination.

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A multi-center randomized phase II study of nivolumab in combination with gemcitabine/cisplatin or ipilimumab as first line therapy for patients with advanced unresectable biliary tract cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.15_suppl.tps4142 ◽

2018 ◽

Vol 36 (15_suppl) ◽

pp. TPS4142-TPS4142 ◽

Cited By ~ 3

Author(s):

Vaibhav Sahai ◽

Kent A. Griffith ◽

Muhammad Shaalan Beg ◽

Mark Zalupski

Keyword(s):

Biliary Tract ◽

Phase Ii ◽

Biliary Tract Cancer ◽

Phase Ii Study ◽

First Line ◽

Tract Cancer ◽

First Line Therapy ◽

Line Therapy ◽

Randomized Phase Ii

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AB061. P-32. Multicenter, randomized phase II trial of S-1, leucovorin, oxaliplatin and gemcitabine (SLOG) in chemo-naïve advanced biliary tract cancer: a Taiwan Cooperative Oncology Group study

HepatoBiliary Surgery and Nutrition ◽

10.21037/hbsn.2019.ab061 ◽

2019 ◽

Vol 8 (S1) ◽

pp. AB061-AB061

Author(s):

Jen-Shi Chen ◽

Li-Yuan Bai ◽

Ming-Huang Chen ◽

Nai-Jung Chiang ◽

Chiun Hsu ◽

...

Keyword(s):

Biliary Tract ◽

Phase Ii ◽

Biliary Tract Cancer ◽

Phase Ii Trial ◽

Oncology Group ◽

Oncology Group Study ◽

Tract Cancer ◽

Randomized Phase Ii

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Treatment of Patients with Advanced Biliary Tract Cancer with Either Oxaliplatin, Gemcitabine, and Capecitabine or Cisplatin and Gemcitabine—A Randomized Phase II Trial

Cancers ◽

10.3390/cancers12071975 ◽

2020 ◽

Vol 12 (7) ◽

pp. 1975

Author(s):

Alice Markussen ◽

Lars Henrik Jensen ◽

Laura Vittrup Diness ◽

Finn Ole Larsen

Keyword(s):

Biliary Tract ◽

Phase Ii ◽

Biliary Tract Cancer ◽

Median Overall Survival ◽

Phase Ii Trial ◽

Progression Free Survival ◽

Tumor Control ◽

Free Survival ◽

Tract Cancer ◽

Randomized Phase Ii

This study is an investigator-initiated randomized phase II trial focusing on the treatment of advanced biliary tract cancer with either oxaliplatin 50 mg/m2 and gemcitabine 1000 mg/m2 on day 1 in a two-week cycle with capecitabine 650 mg/m2 twice-daily continuously or cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 on day 1 and day 8 in a three-week cycle. One-hundred patients were included. Forty-seven patients received oxaliplatin, gemcitabine, and capecitabine with a median progression-free survival (mPFS) of 5.7 months (95% CI 3.0–7.8) and a median overall survival (mOS) of 8.7 months (95% CI 6.5–11.2). Forty-nine patients received cisplatin and gemcitabine with a mPFS of 7.3 months (95% CI 6.0–8.7) and a mOS of 12.0 months (95% CI 8.3–16.7). This trial confirms a mOS of 12 months with cisplatin and gemcitabine, as found in earlier trials. With a superior tumor control rate of 79% vs. 60% (p = 0.045), a difference in the mPFS of 1.6 months (HR = 0.721, p = 0.1), and a difference in the mOS of 3.3 months (HR = 0.731, p = 0.1), cisplatin and gemcitabine should still be considered the standard first-line treatment for advanced biliary tract cancer.

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E7208: A randomized phase II trial of irinotecan and cetuximab (IC) versus IC plus ramucirumab (ICR) in second line therapy of KRAS wild type colorectal cancer (CRC).

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.tps793 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. TPS793-TPS793 ◽

Cited By ~ 1

Author(s):

Howard S. Hochster ◽

Paul J. Catalano ◽

Edith P. Mitchell ◽

Deirdre Jill Cohen ◽

Peter J. O'Dwyer ◽

...

Keyword(s):

Phase Ii ◽

Phase Ii Trial ◽

Bowel Perforation ◽

Second Line ◽

Wild Type ◽

First Line ◽

Second Line Therapy ◽

Line Therapy ◽

Randomized Phase Ii ◽

Grade 3

TPS793 Background: Anti-angiogenic therapy for CRC has been accepted as standard therapy with approval of bevacizumab (bev) in both first-line and second-line settings. At the time this study was started, the benefit of continuing an anti-angiogenic in second line therapy was unproven. Ramucirumab (RAM, IMC 1121b) is a humanized antibody directed against the VEGF-R2 receptor, which may prove to have different activity compared to anti-VEGF antibody (bev). Additionally, while combining the anti-EGFR antibody, cetuximab (CMAB), with bev in first-line unselected patients was not effective, it is unknown whether the same may be true with RAM plus CMAB in a second-line setting for KRAS-selected patients. Methods: The study was designed as a randomized phase II trial with 147 patients assigned to IC = irinotecan (I) 180 mg/m2 IV plus CMAB 500 mg/m2 IV q2w versus ICR = IC plus RAM 8 mg/kg IV q2w. Eligibility included prior treatment on one prior oxaliplatin and bev-containing regimen and progression within 42 days of last bev, PS 0-1, KRAS codon 12,13 wild-type and standard other chemo and bev criteria. Doses were modified for neutropenia, diarrhea, mucositis, rash and grade 3 other toxicities. The study was activated 10/8/10. The first 35 patients were enrolled and accrual was held 6/24/12 for toxicity analysis per protocol. More grade 3 events of mucositis, diarrhea, neutropenia and perforation events (including peri-rectal abscesses) were seen in the ICR arm. The study has been modified reflect the actual doses received, and now uses modified ICR (mICR) = I 150 mg/m2, CMAB 400 mg/m2 and RAM 6 mg/kg IV q2w. The study was re-activataed in May 2014. An additional 100 pts will be accrued to the revised study, giving 85% power to detect improved median PFS from 4.5 to 7.65 months. New eligibility criteria include any progression from first-line chemo (on or off), normal albumin, no bowel perforation or obstruction in last 6 months. This study is now open to accrual in ECOG-ACRIN and in SWOG with endorsement, and via CTSU. Clinical trial information: NCT01079780.

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