1609 Final results from PAVES, a phase 3, randomized, double-blind, placebo-controlled trial of pegfilgrastim in patients (pts) receiving first-line FOLFOX or FOLFIRI and bevacizumab for locally advanced or metastatic colorectal cancer (LA/mCRC) (NCT00911170)

2015 ◽  
Vol 51 ◽  
pp. S241
Author(s):  
T. Pinter ◽  
P.K. Morrow ◽  
A. Cesas ◽  
A. Croitoru ◽  
J. Decaestecker ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Controlled Trial ◽  
Locally Advanced ◽  
First Line ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo

Randomized, Controlled Trial of Irinotecan Plus Infusional, Bolus, or Oral Fluoropyrimidines in First-Line Treatment of Metastatic Colorectal Cancer: Results From the BICC-C Study

2007 ◽  
Vol 25 (30) ◽  
pp. 4779-4786 ◽  
Author(s):  
Charles S. Fuchs ◽  
John Marshall ◽  
Edith Mitchell ◽  
Rafal Wierzbicki ◽  
Vinod Ganju ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Controlled Trial ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Primary Study ◽  
Line Treatment ◽  
First Line ◽  
Double Blind ◽  
First Line Treatment

PurposeThis phase III study compared the safety and efficacy of the following three different irinotecan-containing regimens in the first-line treatment of metastatic colorectal cancer: irinotecan plus infusional fluorouracil (FU)/leucovorin (LV) (FOLFIRI), irinotecan plus bolus FU/LV (mIFL), and irinotecan plus oral capecitabine (CapeIRI).Patients and MethodsA total of 430 previously untreated metastatic colorectal cancer patients were randomly assigned to receive FOLFIRI (n = 144), mIFL (n = 141), or CapeIRI (n = 145). Patients were concurrently randomly assigned to a double-blind treatment with celecoxib or placebo. After a protocol amendment, an additional 117 patients were randomly assigned to either FOLFIRI plus bevacizumab (FOLFIRI+Bev; n = 57) or mILF plus bevacizumab (mIFL+Bev; n = 60), whereas the CapeIRI arm was discontinued. The primary study end point was progression-free survival (PFS), with secondary end points of overall survival (OS), response rate, and toxicity.ResultsMedian PFS was 7.6 months for FOLFIRI, 5.9 months for mIFL (P = .004 for the comparison with FOLFIRI), and 5.8 months for CapeIRI (P = .015). Median OS was 23.1 months for FOLFIRI, 17.6 months for mIFL (P = .09), and 18.9 months for CapeIRI (P = .27). CapeIRI was associated with higher rates of severe vomiting, diarrhea, and dehydration. After the amendment to add bevacizumab, the median survival time has not yet been reached for FOLFIRI+Bev and was 19.2 months for mIFL+Bev (P = .007). FOLFIRI+Bev was associated with a higher rate of ≥ grade 3 hypertension than mIFL+Bev.ConclusionFOLFIRI and FOLFIRI+Bev offered superior activity to their comparators and were comparably safe. An infusional schedule of FU should be the preferred irinotecan-based regimen in first-line metastatic colorectal cancer.

scholarly journals Delta Tocotrienol as a Supplement to FOLFOXIRI in First Line Treatment of Metastatic Colorectal Cancer. A Randomized, Double-blind, Placebo-controlled Phase II Study

2022 ◽  
Author(s):  
Louise Raunkilde ◽  
Torben Frøstrup Hansen ◽  
Birgitte Mayland Havelund ◽  
Caroline Brenner Thomsen ◽  
Søren Rafael Rafaelsen ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Placebo Group ◽  
Metastatic Colorectal Cancer ◽  
Neuroprotective Effect ◽  
First Line ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Triplet Chemotherapy ◽  
Significant Difference ◽  
Dose Reductions

Abstract Purpose Triplet chemotherapy might be more effective than doublet chemotherapy in metastatic colorectal cancer (mCRC), but it may also be marked by increased toxicity. To investigate whether δ-tocotrienol, a vitamin E analogue, with its possible neuroprotective and anti-inflammatory effects reduces the toxicity of triplet chemotherapy, we conducted a randomized, double-blind, placebo controlled trial in mCRC patients receiving first line 5-fluorouracil, oxaliplatin and irinotecan (FOLFOXIRI).Methods We randomly assigned 70 mCRC patients to FOLFOXIRI plus δ-tocotrienol or FOLFOXIRI plus placebo. FOLFOXIRI was given in eight cycles followed by four cycles of 5-fluorouracil. δ-tocotrienol 300 mg or placebo x 3 daily was added during chemotherapy and for a maximum of two years. The primary endpoint was time to hospitalization or death during treatment with chemotherapy.Results Median time to first hospitalization or death was 3.7 months in the placebo group (95% CI 1.93-not reached (NR)), and NR in the δ-tocotrienol group (95% CI 1.87-NR) with a hazard ratio (HR) of 0.70 (95% CI 0.36-1.36, p=0.29)). In the placebo group 24 patients (71%) had oxaliplatin dose reductions compared to 17 patients (47%) in the δ-tocotrienol group (p=0.047).Conclusion The addition of δ-tocotrienol to FOLFOXIRI did not significantly prolong the time to first hospitalization or death compared to FOLFOXIRI plus placebo. Toxicity was manageable and not statistically different between the two groups. There was a statistically significant difference in dose reductions of oxaliplatin pointing to a possible neuroprotective effect of δ-tocotrienol.Clinicaltrials.gov identifier NCT02705300. Date of registration March 10, 2016.

Integrate II: A randomised phase 3 double-blind placebo-controlled study of regorafenib in refractory advanced gastro-oesophageal cancer (AGOC)—An international study organized by the Australasian Gastrointestinal Trials Group (AGITG).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS4136-TPS4136 ◽  
Author(s):  
Katrin Marie Sjoquist ◽  
Nick Pavlakis ◽  
Andrew James Martin ◽  
Eric Tsobanis ◽  
Sonia Yip ◽  
...  
Keyword(s):  
Kinase Inhibitor ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Predictive Biomarkers ◽  
Phase Iii ◽  
Controlled Study ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Geographical Regions

TPS4136 Background: AGOC has a poor prognosis with no established standard treatment following failure of chemotherapy (CT). Regorafenib (BAY 73-4506)(REG) is an oral multi-kinase inhibitor targeting kinases involved in angiogenesis (VEGFR1-3, TIE-2), tumor microenvironment (PDGFR-β, FGFR), and oncogenesis (RAF, RET and KIT). INTEGRATE (phase 2) demonstrated REG was highly effective in prolonging PFS across a range of AGOC pts, with a positive OS trend. Regional differences were found in magnitude of effect, but REG was effective in all regions/subgroups. The phase 3 INTEGRATE II will explore whether REG is effective in prolonging survival in patients overall, and in the Asian sub-population. Methods: International (Australia/New Zealand (NHMRC CTC); Canada (CCTG), Korea, Japan, Taiwan, USA (ACCRU)) randomised phase III, double-blind, placebo-controlled trial with 2:1 (REG:placebo)(PBO) randomisation and stratification by: Location of tumour, Geographic region, prior VEGF inhibitors. Eligible patients (histologically confirmed AGOC), with evaluable metastatic or locally advanced disease refractory to, or relapsed following second line CT, will receive best supportive care plus 160mg REG or matched placebo orally on days 1-21 of each 28 day cycle until disease progression or prohibitive adverse events. Primary endpoint is OS. Secondary endpoints: PFS, response rate, quality of life, safety, identification of prognostic/predictive biomarkers for study endpoints, and REG PK across geographical regions. 350 patients (50% from Asia) randomized in a 2:1 ratio will provide 90% power to detect a hazard ratio (HR) for OS of 0.67 with a 2-sided α of 0.05 assuming PBO median survival is 4.5 mos. The sample size accommodates 2 interim analyses undertaken at 1/3 and 2/3 of required events. As of January 2017, 12 of 28 planned ANZ sites are open, with 4 patients enrolled. Regulatory approval has been received for 12 Canadian sites, and 12 Korean sites. Korean recruitment is expected to commence in February 2017. Regulatory submissions are pending in Taiwan, Japan, and the USA. Clinical trial information: NCT02773524.

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