9-Aminocamptothecin (9-AC) given as a 120-hour continuous infusion in patients with advanced adenocarcinomas of the stomach and gastroesophageal junction: A phase II trial of the University of Chicago phase II consortium

Investigational New Drugs

Volumn 22, Issue 3, 2004, Pages 323-327

  Kindler, Hedy L ^a,c   Avadhani, Anjali ^a   Wade Oliver, Kurombi ^a   Karrison, Theodore ^a   Mani, Sridhar ^b   Vokes, Everett E ^a  

^a UNIVERSITY OF CHICAGO   (United States)

^b MONTEFIORE MEDICAL CENTER   (United States)

^c UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

Author keywords

9 aminocamptothecin; Clinical trial; Gastric cancer; Gastroesophageal junction

Indexed keywords

9 AMINOCAMPTOTHECIN;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; BLOOD TOXICITY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; COLLOID; CONTINUOUS INFUSION; DEHYDRATION; DISEASE COURSE; DISEASE SEVERITY; DRUG EFFICACY; DRUG FORMULATION; EDEMA; ESOPHAGUS CARCINOMA; FATIGUE; FEMALE; FEVER; HUMAN; HYPERGLYCEMIA; HYPOKALEMIA; INFECTION; LOWER ESOPHAGUS SPHINCTER; LYMPHOCYTOPENIA; MALE; METASTASIS; NAUSEA; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; STOMACH ADENOCARCINOMA; SURVIVAL TIME; THROMBOCYTOPENIA; WEIGHT REDUCTION;

ADENOCARCINOMA; ADULT; AGED; ANTINEOPLASTIC AGENTS; CAMPTOTHECIN; ESOPHAGEAL NEOPLASMS; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; STOMACH NEOPLASMS; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 3543011973     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1023/B:DRUG.0000026259.28395.c2     Document Type: Article

References (18)

1. Jemal A, Murray T, Samuels A et al.: Cancer statistics, 2003. CA Cancer J Clin 53: 5-26, 2003
2. Dragovich T, Kindler HL: Nonsurgical Palliative Therapy of Advanced Gastric Cancer. In: Posner MC, Vokes EE, Weichselbaum R (eds) American Cancer Society Atlas of Clinical Oncology Series: Cancer of the Upper Gastrointestinal Tract. BC Decker, Inc, Hamilton, Ontario, 2002, pp 290-307
3. Vanhoefer U, Rougier P, Wilke H, Ducreux MP, Lacave AJ, Van Cutsem E, Planker M, Santos JG, Piedbois P, Paillot B, Bodenstein H, Schmoll HJ, Bleiberg H, Nordlinger B, Couvreur ML, Baron B, Wils JA: Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: A trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cancer. J Clin Oncol 18: 2648-2657, 2000
4. Takimoto C, Thomas R: The clinical development of 9-Aminocamptothecin. Ann NY Acad Sci 922: 224-236, 2000
5. Thomas RR, Dahut W, Harold N, Grem JL, Monahan BP, Liang M, Band RA, Cottrell J, Llorens V, Smith JA, Corse W, Arbuck SG, Wright J, Chen AP, Shapiro JD, Hamilton JM, Allegra CJ, Takimoto CH: A phase I and pharmacologic study of 9-aminocamptothecin administered as a 120-h infusion weekly to adult cancer patients. Cancer Chemother Pharmacol 48:215-222, 2001
6. Rubin E, Wood V, Bharti A, Trites D, Lynch C, Hurwitz S, Bartel S, Levy S, Rosowsky A, Toppmeyer D: A phase I and pharmacokinetic study of a new camptothecin derivative, 9-aminocamptothecin. Clin Cancer Res 1: 269-276, 1995
7. Simon R: Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials 10: 1-10, 1989
8. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53: 457-481, 1958
9. Pazdur R, Medgyesy DC, Winn RJ, Dakhil SR, Moore DF, Scalzo A, Hoff PM, Arbuck SG, Abbruzzesse JL: Phase II trial of 9-aminocamptothecin (NSC 603071) administered as a 120-hour continuous infusion weekly for three weeks in metastatic colorectal carcinoma. Invest New Drugs 16: 341-346, 1999
10. Pazdur R, Diaz-Canton E, Ballard WP, Bradof JE, Graham S, Arbuck SG, Abbruzzese JL, Winn R: Phase II trial of 9-aminocamptothecin administered as a 72-hour continuous infusion in metastatic colorectal carcinoma. J Clin Oncol 15: 2905-2909, 1997
11. Vokes EE, Gordon GS, Rudin CM, Mauer AM, Watson S, Krauss S, Arrieta R, Golomb H, Hoffman PC: A phase II trial of 9-aminocamptothecin (9-AC) as a 120-h infusion in patients with non-small cell lung cancer. Invest New Drugs 19: 329-333, 2001
12. Vokes EE, Ansari RH, Masters GA, Hoffman PC, Klepsch A, Ratain MJ, Sciortino DF, Lad TE, Krauss S, Fishkin PAS, Golomb HM: A phase II study of 9-aminocamptothecin in advanced non-small cell lung cancer. Annals of Oncology 9: 1085-1090, 1998
13. Lad T, Rosen F, Sciortino D, Brockstein B, Keubler JP, Arietta R, Vokes EE: Phase II trial of aminocamptothecin (9-AC/DMA) in patients with advanced squamous cell head and neck cancer. Invest New Drugs 18: 261-263, 2000
14. McCarthy N, Sarosy G, Minasian L, Davis P, Tomkins A, Dyer V, Jones-Wells A, Smith J, Kohler D, Takimoto C, Figg WD, Kohn EC, Reed E: Phase II and pharmacokinetic (PK) study of 9-aminocamptothecin (9AC) in recurrent epithelial ovarian cancer. Proc Am Soc Clin Oncol 18: 363a, 1999
15. Speyer J, Hochster H, Mandeli J, Krook J, Runowicz C, Wadler S: Phase II study of 72 hr 9-amino-camptothecin (9AC) infusion in second-line therapy of ovarian cancer (a NYGOG and ECOG study). Proc Am Soc Clin Oncol 18: 363a, 1999
16. Saltz LB, Schwartz GK, Ilson DH, Quan V, Kelsen DP: A phase II study of topotecan administered five times daily in patients with advanced gastric cancer. Am J Clin Oncol 20: 621-625, 1997
17. Bleiberg H: CPT-11 in gastrointestinal cancer. Eur J Cancer 35: 371-379, 1999
18. Boku N, Ohtsu A, Shimada Y, Shirao K, Seki S, Saito H, Sakata Y, Hyodo I: Phase II study of a combination of irinotecan and cisplatin against metastatic gastric cancer. J Clin Oncol 17: 319-323, 1999