Phase II trial of flavopiridol, a cyclin dependent kinase inhibitor, in untreated metastatic malignant melanoma

Investigational New Drugs

Volumn 22, Issue 3, 2004, Pages 315-322

  Burdette Radoux, Susan ^a,h   Tozer, Richard G ^b   Lohmann, Reinhard C ^c   Quirt, Ian ^d   Ernst, D Scott ^e   Walsh, Wendy ^f   Wainman, Nancy ^f   Colevas, A Dimitrios ^g   Eisenhauer, Elizabeth A ^f  

^a MCGILL UNIVERSITY   (Canada)

^b JURAVINSKI CANCER CENTRE   (Canada)

^c LONDON REGIONAL CANCER PROGRAM   (Canada)

^d PRINCESS MARGARET HOSPITAL   (Canada)

^e TOM BAKER CANCER CENTRE   (Canada)

^f Queen's Cancer Research Institute   (Canada)

^g NATIONAL CANCER INSTITUTE   (United States)

^h UNIVERSITY OF VERMONT   (United States)

Author keywords

Cyclin; Cyclin dependent kinase; Flavopiridol; Melanoma

Indexed keywords

ANTIDIARRHEAL AGENT; ANTIEMETIC AGENT; BISMUTH SALICYLATE; CYCLIN DEPENDENT KINASE; CYCLIN DEPENDENT KINASE INHIBITOR; FLAVOPIRIDOL; LOPERAMIDE; ONDANSETRON;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; BLEEDING; BLOOD TOXICITY; CANCER ADJUVANT THERAPY; CANCER IMMUNOTHERAPY; CARDIOVASCULAR SYMPTOM; CHEMOTHERAPY INDUCED EMESIS; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; DESQUAMATION; DIARRHEA; DISEASE SEVERITY; DRUG ACTIVITY; DYSPEPSIA; DYSPNEA; EXTRAPYRAMIDAL SYMPTOM; EYE DISEASE; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; FLUSHING; GASTROINTESTINAL SYMPTOM; GRANULOCYTOPENIA; HEADACHE; HEARTBURN; HISTOLOGY; HUMAN; HUMAN TISSUE; HYPERGLYCEMIA; HYPERHIDROSIS; HYPOTENSION; INFECTION; LEUKOPENIA; LUNG DISEASE; MALE; MELANOMA; METASTASIS; MYALGIA; NAUSEA; NEUROLOGIC DISEASE; NEUROPATHY; NEUTROPENIA; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RASH; RIGOR; TASTE DISORDER; THROMBOCYTOPENIA; VISUAL IMPAIRMENT;

ADULT; AGED; ANOREXIA; ANTINEOPLASTIC AGENTS; CYCLIN-DEPENDENT KINASES; DIARRHEA; FATIGUE; FEMALE; FLAVONOIDS; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MELANOMA; MIDDLE AGED; NEOPLASM METASTASIS; PIPERIDINES; TREATMENT OUTCOME; VOMITING;

EID: 3542996265     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1023/B:DRUG.0000026258.02846.1c     Document Type: Article

References (28)

1. Ries LAG, Eisner MP, Kosary CL, Hankey BF, Miller BA, Clegg L, Edwards BK (eds): SEER Cancer Statistics Review, 1973-1999, National Cancer Institute. Bethesda, MD, 2002. http://seer.cancer.gov/csr/1973_1999
2. National Cancer Institute of Canada: Canadian Cancer Statistics, Toronto, Canada, 2002. http://www.ncic.cancer.ca
3. Balch CM, Buzaid AC, Soong SJ, Atkins MB, Cascinelli N, Coit DG, Fleming ID, Gershenwald JE, Houghton A Jr, Kirkwood JM, McMasters KM, Mihm MF, Morton DL, Reintgen DS, Ross MI, Sober A, Thompson JA, Thompson JF: Final version of the American Joint Committee on Cancer staging system for cutaneous melanoma. J Clin Oncol 19: 3635-3648, 2001
4. Lakhani S, Selby P, Bliss JM, Perren TJ, Gore ME, McElwain TJ: Chemotherapy for malignant melanoma: Combinations and high doses produce more responses without survival benefit. Br J Cancer 61: 330-334, 1990
5. Kirkwood JM: Melanoma. In: De Vita VT, Hellman S, Rosenberg SA (eds) Biologic Therapy of Cancer. Lippincott. Philadephia, 1995, pp 388-411
6. Legha SS, Ring S, Eton O, Bedikian A, Buzaid AC, Plager C, Papadopoulos N: Development of a biochemotherapy regimen with concurrent administration of cisplatin, vinblastine, dacarbazine, interferon alfa, and interleukin-2 for patients with metastatic melanoma. J Clin Oncol 16: 1752-1759, 1998
7. Tang L, Li G, Tron VA, Trotter MJ, Ho VC: Expression of cell cycle regulators in human cutaneous malignant melanoma. Melanoma Res 9: 148-154, 1999
8. Rizos H, Darmanian AP, Indsto JO, Shannon JA, Kefford RF, Mann GJ: Multiple abnormalities of the p16INK4a-pRb regulatory pathway in cultured melanoma cells. Melanoma Res 9: 10-19, 1999
9. Carlson BA, Dubay MM, Sausville EA, Brizuela L, Worland PJ: Flavopiridol induces G1 arrest with inhibition of cyclin-dependent kinase (CDK)2 and CDK4 in human breast carcinoma cells. Cancer Res 56: 2973-2978, 1996
10. Carlson BA, Pearlstein RA, Naik RG, Sedlacek HH, Sausville EA, Worland PJ: Inhibition of CDK2, CDK4, and CDK7 by flavopiridol and structural analogues (Abstract). Proc Am Assoc Cancer Res 37: 424, 1996
11. Bible KC, Kaufmann SH: Flavopiridol. A cytotoxic flavone that induces cell death in noncycling A549 human lung carcinoma cells. Cancer Res 56: 4856-4861, 1996
12. Kaur G, Stetler-Stevenson M, Sebers S, Worland P, Sedlacek H, Myers C, Czech J, Naik R, Sausville E: Growth inhibition with reversible cell-cycle arrest of carcinoma cells by flavone L86-8275. J Natl Cancer Inst 84: 1736-1749, 1992
13. Investigator's Brochure, HMR 1275, 1st edition. Hoechst Marion Roussel, Inc., Bridgewater, NJ 1998
14. Patel V, Senderowicz AM, Pinto D Jr, Igishi T, Raffeld M, Quintanilla-Martinez L, Ensley JF, Sausville EA, Gutkind JS: Flavopiridol, a novel cyclin-dependent kinase inhibitor, suppresses the growth of head and neck squamous cell carcinomas by inducing apoptosis. J Clin Invest 102: 1674-1681, 1998
15. Arguello F, Alexander M, Sterry JA, Tudor G, Smith EM, Kalavar NT, Greene JF Jr, Koss W, Morgan CD, Stinson SF, Siford TJ, Alvord WG, Klabansky RL, Sausville EA: Flavopiridol induces apoptosis of normal lymphoid cells, causes immunosuppression, and has potent antitumor activity in vivo against human leukemia and lymphoma xenografts. Blood 91: 2482-2490, 1998
16. Senderowicz AM, Headlee D, Stinson SF, Lush RM, Kalil N, Villalba L, Hill K, Steinberg SM, Figg WD, Tompkins A, Arbuck SG, Sausville EA: Phase I trial of continuous infusion flavopiridol, a novel cyclin-dependent kinase inhibitor in patients with refractory neoplasms. J Clin Oncol 16: 2986-2999, 1998
17. Stadler WM, Vogelzang NJ, Amato R, Sosman J, Taber D, Liebowitz D, Vokes EE: Flavopiridol, a novel cyclin-dependent kinase inhibitor, in metastatic renal cancer: A University of Chicago Phase II Consortium study. J Clin Oncol 18: 371-375, 2000
18. Schwartz GK, Ilson D, Saltz L, O'Reilly E, Tong W, Maslak P, Werner J, Perkins P, Stoltz M, Kelsen D: Phase II study of the cyclin-dependent kinase inhibitor flavopiridol administered to patients with advanced gastric carcinoma. J Clin Oncol 19: 1985-1992, 2001
19. Shapiro GI, Supko JG, Patterson A, Lynch C, Lucca J, Zacarola PF, Muzikansky A, Wright JJ, Lynch TJ Jr, Rollins BJ: A phase II trial of the cyclin-dependent kinase inhibitor flavopiridol in patients with previously untreated stage IV non-small cell lung cancer. Clinical Cancer Research 7: 1590-1599, 2001
20. Tan AR, Headlee D, Messmann R, Sausville EA, Arbuck SG, Murgo AJ, Melillo G, Zhai S, Figg WD, Swain SM, Senderowicz AM: Phase I clinical and pharmacokinetic study of flavopiridol administered as a daily 1-hour infusion in patients with advanced neoplasms. J Clin Oncol 20: 4074-4082, 2002.
21. National Cancer Institute Clinical Trials Evaluation Program Common Toxicity Criteria Version 2.0, 6/99 update. http://ctep.cancer.gov/forms/ CTCManual_v4_10-4-99.pdf
22. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG: New guidelines to evaluate the response to treatments in solid tumors (RECIST guidelines). J Natl Cancer Inst 92: 205-216, 2000
23. Li Y, Chinni SR, Senderowicz AM, Sarkar FH: Induction of growth inhibition and apoptosis in prostate cancer cells by flavopiridol. Int J Oncol 17: 755-759, 2000
24. Robey RW, Medina-Perez WY, Nishiyama K, Lahusen T, Miyake K, Litman T, Senderowicz AM, Ross DD, Bates SE: Overexpression of the ATP-binding cassette half-transporter, ABCG2 (Mxr/BCrp/ABCP1), in flavopiridol-resistant human breast cancer cell lines. Clinical Cancer Research 7: 145-152, 2001
25. Smith V, Raynaud F, Workman P, Kelland LR: Characterization of a human colorectal carcinoma cell line with acquired resistance to flavopiridol. Molecular Pharmacology 60: 885-893, 2001
26. Kahn ME, Senderowicz A, Sausville EA, Barrett KE: Possible mechanisms of diarrheal side effects associated with the use of a novel chemotherapeutic agent, flavopiridol. Clinical Cancer Research 7: 343-349, 2001
27. Bernhard J, Thurlimann B, Schmitz SF, Castiglione-Gertsch M, Cavalli F, Morant R, Fey MF, Bonnefoi H, Goldhirsch A, Hurny C: Defining clinical benefit in postmenopausal patients with breast cancer under second-line endocrine treatment: does quality of life matter? J Clin Oncol 17: 1651-1653, 1999
28. Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD: Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial. J Clin Oncol 15: 2403-2413, 1997