Randomized Phase III Trial Exploring the Use of Long-Acting Release Octreotide in the Prevention of Chemotherapy-Induced Diarrhea in Patients With Colorectal Cancer: The LARCID Trial

2014 ◽  
Vol 32 (10) ◽  
pp. 1006-1011 ◽  
Author(s):  
Paulo M. Hoff ◽  
Daniel F. Saragiotto ◽  
Carlos H. Barrios ◽  
Auro del Giglio ◽  
Anelisa K. Coutinho ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Common Adverse Event ◽  
Phase Iii ◽  
Control Group ◽  
Phase Iii Trial ◽  
Octreotide Lar ◽  
Intravenous Hydration ◽  
Long Acting ◽  
To Receive

PurposeChemotherapy-induced diarrhea (CID) is a relatively common adverse event in the treatment of patients with colorectal cancer. The LAR for Chemotherapy-Induced Diarrhea (LARCID) trial evaluated the efficacy and safety of long-acting release octreotide (octreotide LAR) for the prevention of CID in this population.Patients and MethodsPatients with colorectal cancer starting adjuvant or first-line treatment with a chemotherapy combination containing fluorouracil, capecitabine, and/or irinotecan were randomly assigned to receive octreotide LAR 30 mg intramuscularly every 4 weeks (experimental arm) or the physician's treatment of choice in case of diarrhea (control arm).ResultsA total of 139 patients were randomly assigned, most of whom received fluorouracil- and oxaliplatin-containing chemotherapy regimens. The rate of diarrhea was 76.1% in the experimental group (n = 68) and 78.9% in the control group (n = 71). Treatment with octreotide LAR did not prevent or reduce the severity of CID. Treatment choices for diarrhea management included loperamide in the majority of patients. No benefit from octreotide LAR was identified in terms of need for diarrhea treatment, opioids, or intravenous hydration or in the rate of hospitalization or quality of life.ConclusionThis study could not prove the efficacy of octreotide LAR in the prevention of CID.

A randomized phase III trial exploring the use of long-acting release octreotide in the prevention of chemotherapy-induced diarrhea in patients with colorectal cancer: The LARCID trial.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 549-549 ◽  
Author(s):  
Paulo Marcelo Hoff ◽  
Daniel Fernandes Saragiotto ◽  
Carlos H. Barrios ◽  
Auro Del Giglio ◽  
Anelisa Kruschewsky Coutinho ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Common Adverse Event ◽  
Phase Iii ◽  
Control Group ◽  
Octreotide Lar ◽  
Intravenous Hydration ◽  
Long Acting ◽  
Colorectal Cancer Patients

549 Background: Chemotherapy-induced diarrhea (CID) is a relatively common adverse event in the treatment of colorectal cancer patients. The LARCID trial evaluated the efficacy and safety of long-acting release octreotide (octreotide LAR) for the prevention of CID in this population. Methods: Colorectal cancer patients starting adjuvant or first-line treatment with a chemotherapy combination containing fluorouracil (5-FU), capecitabine and/or irinotecan were randomized to receive octreotide LAR, 30 mg intramuscularly every 4 weeks, (experimental arm) or the physician’s treatment of choice in case of diarrhea (control arm). Results: A total of 139 patients were randomized, most of which received 5-FU- and oxaliplatin-containing chemotherapy regimens. The rate of diarrhea was 76.1% in the experimental group (n=68) and 78.9% in the control group (n=71). Treatment with octreotide LAR did not prevent nor reduced the severity of CID. Treatment choices for diarrhea management included loperamide in the majority of cases. No benefit from octreotide LAR was identified in terms of need for diarrhea treatment, opioids, or intravenous hydration, nor in the rate of hospitalization, or quality-of-life. Conclusions: Octreotide LAR is not indicated for the prevention of CID.

Steroid-free regimen with aprepitant in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX chemotherapy: A randomized phase III trial.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. TPS820-TPS820
Author(s):  
Wenjing Wang ◽  
Jiayu Ling ◽  
Yue Cai ◽  
Jianwei Zhang ◽  
Huabin Hu ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Receptor Antagonist ◽  
Rescue Medication ◽  
Performance Status ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Open Label ◽  
Phase Iii Trial ◽  
Delayed Nausea ◽  
To Receive

TPS820 Background: Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX (oxaliplatin, leucovorin and 5-fluorouracil) chemotherapy. Methods: This trial is an open-label, single-center, randomized phase 2 study. Eligibility criteria include histologically confirmed colorectal cancer, no prior chemotherapy and scheduled to receive FOLFOX, Age ≥ 18 years, ECOG Performance Status 0, 1 or 2. Up to 298 patient will be enrolled and randomized 1:1 to receive aprepitant (125 mg orally on day 1 and 80 mg orally on days 2 and 3) plus tropisetron (5mg IV of day1) or dexamethasone (10 mg IV on day 1 and 5 mg IV on days 2, 3) plus Tropisetron (5mg IV of day1). The primary objective of this study is complete response defined as no emetic episodes and no use of rescue medication. The second objectives include nausea score, time to first vomiting episode or use of rescue medication, frequency of rescue medication and functional Living Index -Emesis (FLIE). Clinical trial information: NCT02909478.

Results of a Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of Trifluridine/Tipiracil (TAS-102) Monotherapy in Asian Patients With Previously Treated Metastatic Colorectal Cancer: The TERRA Study

2018 ◽  
Vol 36 (4) ◽  
pp. 350-358 ◽  
Author(s):  
Jianming Xu ◽  
Tae Won Kim ◽  
Lin Shen ◽  
Virote Sriuranpong ◽  
Hongming Pan ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Metastatic Colorectal Cancer ◽  
Biologic Therapy ◽  
Phase Iii ◽  
Double Blind ◽  
Phase Iii Trial ◽  
Double Blind Placebo ◽  
Asian Patients ◽  
To Receive

Purpose Trifluridine/tipiracil (TAS-102) was effective in patients with metastatic colorectal cancer (mCRC) in a phase II Japanese trial. This regional trial evaluated the efficacy and safety of trifluridine/tipiracil in Asian patients with mCRC with or without exposure to biologic therapy. Patients and Methods This randomized, double-blind, placebo-controlled, phase III trial was conducted at 30 sites in China, the Republic of Korea, and Thailand. Patients ≥ 18 years old with histologically or cytologically confirmed adenocarcinoma of the colon or rectum and known KRAS status who were refractory or intolerant to two or more prior chemotherapy regimens were enrolled. Eligible patients were randomly assigned (2:1 ratio; minimization method) to receive trifluridine/tipiracil (twice per day orally; 5 days on and 2 days off for 2 weeks, followed by 14 days off per cycle) or placebo. The primary end point was overall survival (intent-to-treat population). Results Between October 16, 2013, and June 15, 2015, 406 patients were randomly assigned to receive trifluridine/tipiracil (n = 271) or placebo (n = 135). Risk of death was significantly lower in the trifluridine/tipiracil arm than in the placebo arm (hazard ratio for death, 0.79; 95% CI, 0.62 to 0.99; log-rank P = .035). Median overall survival was significantly longer in the trifluridine/tipiracil than in the placebo arm (7.8 months [95% CI, 7.1 to 8.8 months] v 7.1 months [95% CI, 5.9 to 8.2 months], respectively), for a median survival follow-up time of 13.8 months (95% CI, 13.1 to 15.3 months) compared with 13.4 months (95% CI, 11.6 to 17.3 months), respectively. The incidence of serious adverse events was similar between the arms (trifluridine/tipiracil, n = 63 [23.2%]; placebo, n = 32 [23.7%]). No treatment-related deaths were reported. Conclusion Trifluridine/tipiracil has a statistically significant survival benefit compared with placebo in Asian patients with mCRC refractory or intolerant to standard chemotherapies, regardless of exposure to biologic therapy. The safety profile is similar to previous reports.

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