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A phase I/II study of Lonsurf combined with Oxaliplatin in metastatic colorectal cancer patients refractory to standard chemotherapy.

ABSTRACT: Interventions: Lonsurf/L-OHP therapy Lonsurf: 70mg/m2, d1-5, d15-19 (fixed dose) L-OHP: 50-85mg/m2, d1,d15 (dose escalation) every 4 weeks Primary outcome(s): [Phase I part] To determine recommended dose (RD) and maximum tolerated dose (MTD) [Phase II part]Disease Control Rate (DCR) Study Design: Single arm Non-randomized

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 2631090 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase 1 Trial of Lonsurf with Irinotecan and Bevacizumab

Project description:Interventions: 1 cycle is 28days. Lonsurf(25mg/m2)is administered orally twice daily in 1-5days and 8-12 days. Irinotecan(100mg/m2) and Bevacizumab(5mg/kg) is administered by injection in day 1 and day15. Primary outcome(s): Recommended dose:RD Study Design: single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose

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Phase I/II study of the combination of Oxaliplatin and S-1 in patients with advanced/recurrent colorectal cancer

Project description:Interventions: S-1 is administered orally at the dose of 40mg/m2 twice a day for 21 days, followed by 7-14 days rest. L-OHP is administered intravenously biweekly(day 1 and 15). On 2nd steps L-OHP is administered with RD intravenously biweekly more than 2 courses. The doses of L-OHP are 70mg/m2 for level 1, 85mg/m2 for level 2, and 55mg/m2 for level 0. Primary outcome(s): Step1:safety;adverse events Step2:Disease control rate Study Design: Single arm Non-randomized

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Phase 1 Trial of Lonsurf with Irinotecan and Bevacizumab in Patients with Unresectable Metastatic Colorectal Cancer(mCRC).

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Use-results survey for Lonsurf combination tablet T15 & Lonsurf combination tablet T20

Project description:Intervention name : Lonsurf combination tablet T15/T20 INN of the intervention : trifluridine + tipiracil hydrochloride Dosage And administration of the intervention : Usually, the standard doses below are defined as the initial dose (single dose) for adults according to body surface area (approximately 35 mg of Trifluridine/m2/dose). Lonsurf is administered twice daily, after breakfast and after the evening meal, for 5 consecutive days, followed by a 2-day rest. After repeating this twice, follows a 14-day rest. This is one cycle of the regimen and it shall be repeated. Study Design: Postmarketing surveillance

| 2611187 | ecrin-mdr-crc

Use-results survey for Lonsurf combination tablet T15 & Lonsurf combination tablet T20

Project description:Interventions: investigational material(s) Generic name etc : Lonsurf combination tablet T15/T20 INN of investigational material : trifluridine + tipiracil hydrochloride Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Usually, the standard doses below are defined as the initial dose (single dose) for adults according to body surface area (approximately 35 mg of Trifluridine/m2/dose). Lonsurf is administered twice daily, after breakfast and after the evening meal, for 5 consecutive days, followed by a 2-day rest. After repeating this twice, follows a 14-day rest. This is one cycle of the regimen and it shall be repeated. Study Design: Postmarketing surveillance

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A Phase II Study of Neoadjuvant Gemcitabine Plus Doxorubicin Followed by Gemcitabine Plus Cisplatin in Breast Cancer

Project description:This phase II study examined the pathological complete response (pCR) rate and safety of two gemcitabine-based combinations administered sequentially in breast cancer. We also examined gene expression profiles from tumor biopsies to identify biomarkers predictive of response. Methods: Indian women with large or locally advanced breast cancer received 4 cycles of gemcitabine 1200 mg/m2 plus doxorubicin 60 mg/m2 (Gem+Dox), then 4 cycles of gemcitabine 1000 mg/m2 plus cisplatin 70 mg/m2 (Gem+Cis), and surgery. To examine dynamic changes in molecular profiles after one dose of therapy, we used three alternate sequences during cycle 1 (Gem d1, 8; Dox d2; Gem d1, 8; Dox d1; or Gem d2, 8; Dox d1). Results: Of 65 women (median age 46) treated, 13 (24.5% of 53 patients with surgery) had a pCR and 22 (33.8%) had a complete clinical response. Patients who received Gem d1, 8 and Dox d2 in cycle 1 (20/65) reported more toxicities, with G3/4 neutropenic infection/febrile neutropenia (7/20) and vomiting (5/20) as the most common cycle 1 events. Four drug-related deaths occurred. 46/65 patients yielded successful pretreatment gene expression profiles. Ten-fold cross-validated supervised analyses identified gene expression patterns that predicted with >73% accuracy (1) clinical complete response after eight cycles, (2) overall clinical complete response, and (3) pCR. Conclusions: This neoadjuvant regimen showed strong activity. A subset of patients receiving Gem d1, 8 and Dox d2 experienced unacceptable toxicity, whereas patients on other sequences had more manageable safety profiles. The predictive gene expression patterns may provide a method for selecting patients most likely to benefit from gemcitabine-containing neoadjuvant therapy. Key words: breast cancer, chemotherapy, gemcitabine, , gene expression, microarrays, neoadjuvant therapy Keywords: Dose response

2008-01-12 | GSE8465 | GEO

First-in-human Study of CA102N Monotherapy and CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors

Project description:Study HS-CA102N-101 is a phase 1, two part (dose escalation, dose expansion), multicenter, non-randomized, open-label, multiple dose, first-in-human study of CA102N monotherapy and of CA102N combined with trifluridine/tipiracil (LONSURF) in subjects with advanced solid tumors. CA102N will be evaluated in subjects with locally advanced or metastatic solid tumours for which no effective therapy is available in Part 1 (dose escalation) and in subjects with relapsed or refractory locally advanced or metastatic colorectal cancer (mCRC) after prior oxaliplatin and irinotecan-based chemotherapy in Part 2 (dose expansion).

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A Phase I /II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy.

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| 2619445 | ecrin-mdr-crc

Study on the effects of metformin and cimetidine on the exposure of trifluridine/tipiracil (lonsurf) in patients with a metastatic colorectal carcinoma

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