Phase i study of weekly kahalalide F as prolonged infusion in patients with advanced solid tumors

Cancer Chemotherapy and Pharmacology

Volumn 72, Issue 1, 2013, Pages 75-83

  Salazar, R ^a   Cortes Funes H ^b   Casado, E ^c   Pardo, B ^a   Lopez Martin A ^b   Cuadra, C ^a   Tabernero, J ^c   Coronado, C ^b   Garcia M ^a   Soto Matos Pita, A ^d   Miguel Lillo, B ^d   Cullell Young, M ^d   Iglesias Dios, J L ^d   Paz Ares, L ^b  

^a CATALAN INSTITUTE OF ONCOLOGY   (Spain)

^b HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^c HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^d PHARMAMAR S A   (Spain)

Author keywords

Advanced solid tumors; Kahalalide; Marine compounds; Phase I clinical trials

Indexed keywords

KAHALALIDE F;

ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILE DUCT CARCINOMA; BILIRUBIN BLOOD LEVEL; BLOOD TOXICITY; COLORECTAL CANCER; CREATININE BLOOD LEVEL; DISTRIBUTION VOLUME; DOSAGE SCHEDULE COMPARISON; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ERUPTION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG MECHANISM; DRUG MEGADOSE; DRUG SAFETY; FATIGUE; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HUMAN; LEUKOPENIA; LIVER CANCER; LUNG NON SMALL CELL CANCER; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MELANOMA; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PANCREAS CANCER; PARESTHESIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RECOMMENDED DRUG DOSE; SIDE EFFECT; SOLID TUMOR; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; COHORT STUDIES; COLORECTAL NEOPLASMS; DEPSIPEPTIDES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG-INDUCED LIVER INJURY; DRUGS, INVESTIGATIONAL; FEMALE; HUMANS; INCIDENCE; INFUSIONS, INTRAVENOUS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASMS; SEVERITY OF ILLNESS INDEX; SPAIN;

EID: 84879794592     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-013-2170-5     Document Type: Article

References (18)

1. Hamann MT, Scheuer PJ (1993) Kahalalide F: a bioactive depsipeptide from the sacoglossan mollusk Elysia rufescens and the green alga Bryopsis sp. J Am Chem Soc 115:5825-5826
2. Hamann MT, Otto CS, Scheuer PJ, Dunbar DC (1996) Kahalalides: bioactive peptides from a marine mollusk elysia rufescens and its algal diet bryopsis sp. (1). J Org Chem 61:6594-6600
3. Lopez-Macia A, Jimenez JC, Royo M, Giralt E, Albericio F (2001) Synthesis and structure determination of kahalalide F (1,2). J Am Chem Soc 123:11398-11401
4. Hanauske AR, Hanauske U, Von Hoff DD (1985) The human tumor clonogenic assay in cancer research and therapy. Curr Probl Cancer 9:1-66
5. Suarez Y, Gonzalez L, Cuadrado A, Berciano M, Lafarga M, Munoz A (2003) Kahalalide F, a new marine-derived compound, induces oncosis in human prostate and breast cancer cells. Mol Cancer Ther 2:863-872
6. Garcia-Rocha M, Bonay P, Avila J (1996) The antitumoral compound Kahalalide F acts on cell lysosomes. Cancer Lett 99:43-50
7. Janmaat ML, Rodriguez JA, Jimeno J, Kruyt FA, Giaccone G (2005) Kahalalide F induces necrosis-like cell death that involves depletion of ErbB3 and inhibition of Akt signaling. Mol Pharmacol 68:502-510
8. Wosikowski K, Schuurhuis D, Johnson K, Paull KD, Myers TG, Weinstein JN, Bates SE (1997) Identification of epidermal growth factor receptor and c-erbB2 pathway inhibitors by correlation with gene expression patterns. J Natl Cancer Inst 89:1505-1515
9. Faircloth G, Cuevas C (2006) Kahalalide F and ES285: potent anticancer agents from marine molluscs. Prog Mol Subcell Biol 43:363-379
10. Rademaker-Lakhai JM, Horenblas S, Meinhardt W, Stokvis E, de Reijke TM, Jimeno JM, Lopez-Lazaro L, Lopez Martin JA, Beijnen JH, Schellens JH (2005) Phase I clinical and pharmacokinetic study of kahalalide F in patients with advanced androgen refractory prostate cancer. Clin Cancer Res 11:1854-1862
11. Pardo B, Paz-Ares L, Tabernero J, Ciruelos E, Garcia M, Salazar R, Lopez A, Blanco M, Nieto A, Jimeno J, Izquierdo MA, Trigo JM (2008) Phase I clinical and pharmacokinetic study of kahalalide F administered weekly as a 1-hour infusion to patients with advanced solid tumors. Clin Cancer Res 14:1116-1123
12. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. European organization for research and treatment of cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216
13. Stokvis E, Rosing H, Lopez-Lazaro L, Rodriguez I, Jimeno JM, Supko JG, Schellens JH, Beijnen JH (2002) Quantitative analysis of the novel depsipeptide anticancer drug Kahalalide F in human plasma by high-performance liquid chromatography under basic conditions coupled to electrospray ionization tandem mass spectrometry. J Mass Spectrom 37:992-1000
14. Stokvis E, Rosing H, Lopez-Lazaro L, Schellens JH, Beijnen JH (2004) Switching from an analogous to a stable isotopically labeled internal standard for the LC-MS/MS quantitation of the novel anticancer drug Kahalalide F significantly improves assay performance. Biomed Chromatogr 18:400-402
15. Martin-Algarra S, Espinosa E, Rubio J, Lopez Lopez JJ, Manzano JL, Carrion LA, Plazaola A, Tanovic A, Paz-Ares L (2009) Phase II study of weekly Kahalalide F in patients with advanced malignant melanoma. Eur J Cancer 45:732-735
16. Gao J, Hamann MT (2011) Chemistry and biology of kahalalides. Chem Rev 111:3208-3235. doi: 10.1021/cr100187n
17. Provencio M, Izquierdo A, Viñolas N, Paz-Ares L, Feliu J, Constenla M, De las Heras B, Erustes M, Izquierdo MA, Rossell R (2006) Phase II clinical trial of Kahalalide F (KF) as a second line therapy in patients (pts) with advanced non-small cell lung cancer (NSCLC). Ann Oncol 17:Abstract #755P
18. Jimeno J, Lopez-Martin JA, Ruiz-Casado A, Izquierdo MA, Scheuer PJ, Rinehart K (2004) Progress in the clinical development of new marine-derived anticancer compounds. Anticancer Drugs 15:321-329