Phase i dose-escalation study of brostallicin, a minor groove binder, in combination with cisplatin in patients with advanced solid tumors

Cancer Chemotherapy and Pharmacology

Volumn 66, Issue 2, 2010, Pages 389-394

  Caponigro, F ^a   Lorusso, D ^b   Fornari, G ^c   Barone, C ^b   Merlano, M ^d   Airoldi, M ^e   Schena, M ^e   MacArthur, R ^f   Weitman, S ^g   Jannuzzo, M G ^h   Crippa, S ^h   Fiorentini, F ⁱ   Petroccione, A ^h   Comis, S ^h  

^a NATIONAL CANCER INSTITUTE   (Italy)

^b CATHOLIC UNIVERSITY   (Italy)

^c Valdese Hospital   (Italy)

^d S CROCE E CARLE HOSPITAL   (Italy)

^e MOLINETTE HOSPITAL   (Italy)

^f S Giovanni Battista Hospital ^*  (United States)

^g MCS   (United States)

^h NERVIANO MEDICAL SCIENCES   (Italy)

ⁱ Nerviano Medical Sciences ^*

Author keywords

Brostallicin; Cisplatin; Phase I; Solid tumors

Indexed keywords

BROSTALLICIN; CISPLATIN; PLATINUM COMPLEX; ANTINEOPLASTIC AGENT; GUANIDINE DERIVATIVE; PYRROLE DERIVATIVE;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASTHENIA; BILIRUBIN BLOOD LEVEL; BLEEDING; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DISEASE FREE SURVIVAL; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FEVER; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HEMATOLOGIC DISEASE; HUMAN; KIDNEY FAILURE; LEG FRACTURE; MAGNESIUM BLOOD LEVEL; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SINGLE DRUG DOSE; SODIUM BLOOD LEVEL; SOLID TUMOR; SQUAMOUS CELL CARCINOMA; THROMBOCYTOPENIA; VOMITING; METASTASIS; MIDDLE AGED; NEOPLASM; SEXUAL DEVELOPMENT;

AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; GUANIDINES; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASMS; PYRROLES; SEX CHARACTERISTICS;

EID: 77953053338     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-009-1175-6     Document Type: Article

References (14)

1. Geroni C, Marchini S, Cozzi P et al (2002) Brostallicin, a novel anticancer agent whose activity is enhanced upon binding to glutathione. Cancer Res 62:2332-2336
2. Lockhart AC, Howard M, Hande KR et al (2004) A phase I doseescalation and pharmacokinetic study of brostallicin (PNU- 166196A), a novel DNA minor groove binder, in adult patients with advanced solid tumors. Clin Cancer Res 10:468-475
3. Ten Tije AJ, Verweij J, Sparreboom A et al (2003) Phase I and pharmacokinetic study of brostallicin (PNU-166196), a new DNA minor-groove binder, administered intravenously every 3 weeks to adult patients with metastatic cancer. Clin Cancer Res 9:2957-2964
4. Sabatino MA, Colombo T, Geroni C, Marchini S, Broggini M (2003) Enhancement of in vivo antitumor activity of classical anticancer agents by combination with the new, glutathione-interacting DNA minor groove-binder, brostallicin. Clin Cancer Res 9:5402-5408
5. Simon R (1989) Optimal two-stage design for phase II clinical trials. Controll Clin Trials 10:1-10
6. D'Incalci M, Sessa C (1997) DNA minor groove binding ligands: a new class of anticancer agents. Expert Opin Invest Drugs 6:875-884
7. Marchini S, Broggini S, Sessa C, D'Incalci M (2001) Development of distamycin-related DNA binding anticancer drugs. Expert Opin Invest Drugs 10:1703-1714
8. Broggini M, Erba E, Ponti M et al (1991) Selective DNA interaction of the novel distamycin derivative FCE 24517. Cancer Res 51:199-204
9. Baker B, Dervan PB (1989) Sequence-specific cleavage of DNA by N-bromoacetyldistamycin. Product and kinetic analyses. J Am Chem Soc 111:2700-2712
10. Sessa C, Pagani O, Zurlo MG et al (1994) Phase I study of the novel distamycin derivative tallimustine (FCE 24517). Ann Oncol 5:901-907
11. Abigerges D, Armand JP, Da Costa L (1993) Distamycin a derivative, FCE 24517: a phase I study in solid tumors. Proc Am Assoc Cancer Res 34:267.
12. Broggini M, Marchini S, Fontana E et al (2004) A new concept in minor groove DNA binder development. Anticancer Drugs 15:1-6
13. Fedier A, Fowst C, Tursi J et al (2003) Brostallicin (PNU- 166196)-a new DNA minor groove binder that retains sensitivity in DNA mismatch repair-deficient tumours cells. Br J Cancer 89:1559-1565
14. Kiefer J, Shanmugam K, Weitman S et al (2008) Application of cellular pharmacogenomics and systems biology to identify contexts of vulnerability and guide the clinical development of brostallicin. Proc Am Assoc Cancer Res (abstr 920)