Irinotecan and Gemcitabine in Patients with Advanced Non-small Cell Lung Cancer, Previously Treated with Cisplatin-based Chemotherapy. A Phase II Study

Anticancer Research

Volumn 23, Issue 5 B, 2003, Pages 4205-4211

  Pectasides, Dimitrios ^a   Mylonakis, Nikolaos ^a   Farmakis, Dimitrios ^a   Nikolaou, Maria ^a   Koumpou, Maria ^a   Katselis, Ioannis ^a   Gaglia, Asimina ^a   Kostopoulou, Vassiliki ^a   Karabelis, Athanasios ^a   Kosmas, Christos ^a  

^a METAXA CANCER HOSPITAL   (Greece)

Author keywords

Gemcitabine; Irinotecan; Refractory advanced non small cell lung cancer

Indexed keywords

CISPLATIN; GEMCITABINE; IRINOTECAN;

ADULT; AGED; ALLERGY; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; CANCER GROWTH; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIARRHEA; DISEASE SEVERITY; DRUG DOSE REDUCTION; DYSPNEA; FATIGUE; FEVER; HEALTH STATUS; HEMOPTYSIS; HOSPITALIZATION; HUMAN; HUMAN CELL; LUNG NON SMALL CELL CANCER; MALE; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT WITHDRAWAL;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DEOXYCYTIDINE; DRUG RESISTANCE, NEOPLASM; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED;

EID: 0344872723     PISSN: 02507005     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (36)

1. Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y and Berille J: Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18: 2095-2103, 2000.
2. Fossella FV, DeVore R, Kerr RN, Crawford J, Natale RR, Dunphy F, Kalman L, Miller V, Lee JS, Moore M, Gandara D, Karp D, Vokes E, Kris M, Kim Y, Gamza F and Hammershaimb L: Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol 18: 2354-2362, 2000.
3. Mogi H, Hasegawa Y, Watanabe A, Nomura F, Saka H and Shimokata K: Combination effects of cisplatin, vinorelbine and irinotecan in non-small-cell lung cancer cell lines in vitro. Cancer Chemother Pharmacol 39: 199-204, 1997.
4. Shimada Y, Rothenberg M, Hilsenbeck SG, Burris HA 3rd, Degen D and Von Hoff DD: Activity of CPT-11 (irinotecan hydrochloride), a topoisomerase I inhibitor, against human tumor colony-forming units. Anticancer Drugs 5: 202-206, 1994.
5. Tamura K, Takada M, Kawase I, Tada T, Kudoh S, Okishio K, Fukuoka M, Yamaoka N, Fujiwara Y and Yamakido M: Enhancement of tumor radio-response by irinotecan in human lung tumor xenografts. Jpn J Cancer Res 88: 218-223, 1997.
6. Fukuoka M, Niitani H, Suzuki A, Motomiya M, Hasegawa K, Nishiwaki Y, Kuriyama T, Ariyoshi Y, Negoro S, Masuda N et al: A phase II study of CPT-11, a new derivative of camptothecin, for previously untreated non-small-cell lung cancer. J Clin Oncol 10: 16-20, 1992.
7. Douillard JY, Ibrahim N, Riviere A, Spaeth D, Chomy P, Soussan K and Mathieu-Boue A: Phase II study of CPT-11 (irinotecan) in non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 14: 365, 1995.
8. Baker L, Khan R, Lynch T, Savaraj N, Sandler A, Feun L, Schaser R, Hanover C and Petit R: Phase II study of irinotecan (CPT-11) in advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 16: 461a, 1997.
9. Boisseau M, Guichard S and Canal P: Irinotecan (CPT-11): Current status and perspectives. Exp Opin Invest Drugs 5: 613-626, 1996.
10. O'Reilly S and Rowinsky EK: The clinical status of irinotecan (CPT-11), a novel water soluble camptothecin analogue: Crit Rev Oncol Hematol 24: 47-70, 1996.
11. Nakai H, Fukuoka M, Furuse K, Nakao I, Yoshimori K, Ogura T, Hara N, Sakata Y, Saito H, Hasegawa K et al: An early phase II study of CPT-11 in primary lung cancer. Gan To Kagaku Ryoho 18: 607-612, 1991.
12. Negoro S, Fukuoka M, Niitani H, Suzuki A, Nakabayashi T, Kimura M, Motomiya M, Kurita Y, Hasegawa K, Kuriyama T et al: A phase II study of CPT-11, a camptothecin derivative, in patients with primary lung cancer. CPT-11 Cooperative Study Group. Gan To Kagaku Ryoho 18: 1013-1019, 1991.
13. Storniolo AM, Allerheiligen SR and Pearce HL: Preclinical, pharmacologic, and phase I studies of gemcitabine. Semin Oncol 24(2 Suppl 7): S7-2-S7-7, 1997.
14. Abratt RP, Bezwoda WR, Falkson G, Goedhals L, Hacking D and Rugg TA: Efficacy and safety profile of gemcitabine in non-small-cell lung cancer: A phase II study. J Clin Oncol 12: 1535-1540, 1994.
15. Gatzemeier U, Shepherd FA, Le Chevalier T, Weynants P, Cottier B, Groen HJ, Rosso R, Mattson K, Cortes-Funes H, Tonato M, Burkes RL, Gottfried M and Voi M: Activity of gemcitabine in patients with non-small cell lung cancer: a multicentre, extended phase II study. Eur J Cancer 32A: 243-248, 1996.
16. Anderson H, Lund B, Bach F, Thatcher N, Walling J and Hansen HH: Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study. J Clin Oncol 12: 1821-1826, 1994.
17. Crino L, Mosconi AM, Scagliotti G, Selvaggi G, Novello S, Rinaldi M, Della Giulia M, Gridelli C, Rossi A, Calandri C, De Marinis F, Noseda M and Tonato M: Gemcitabine as second-line treatment for advanced non-small-cell lung cancer: A phase II trial. J Clin Oncol 17: 2081-2085, 1999.
18. Bahadori HR, Ogretmen B, Rocha-Lima CM, Green MR and Safa AR: Evaluation of irinotecan (CPT-11) and gemcitabine (G) as single agents and in combination in small-cell lung cancer cells. Proc Am Soc Clin Oncol 17: 477a, 1998.
19. Hollen PJ, Gralla RJ, Kris MG and Potanovich LM: Quality of life assessment in individuals with lung cancer: Testing the Lung Cancer Symptom Scale. Eur J Cancer 29A(Suppl 1): 51-58, 1993.
20. Fossella FV, Lee JS and Hong WK: Management strategies for recurrent non-small cell lung cancer. Semin Oncol 24: 455-462, 1997.
21. O'Reilly E, Ilson D, Schwartz G, Tong W, Fata F, Kemeny N, Sherwin K, Sharma S and Kelsen D: A phase I study of combination gemcitabine (gem) and irinotecan (CPT-11) in patients (pts) with refractory solid tumors. Proc Am Soc Clin Oncol 18: 176a, 1999.
22. Rocha Lima CM, Savarese D, Bruckner H, Dudek A, Eckardt J, Hainsworth J, Yunus F, Lester E, Miller W, Saville W, Elfring GL, Locker PK, Compton LD, Miller LL and Green MR: Irinotecan plus gemcitabine induces both radiographic and CA 19-9 tumor marker responses in patients with previously untreated advanced pancreatic cancer. J Clin Oncol 20: 1182-1191, 2002.
23. Kakolyris SS, Kouroussis C, Koukourakis M, Kalbakis K, Mavroudis D, Vardakis N and Georgoulias V: A dose-escalation study of irinotecan (CPT-11) in combination with gemcitabine in patients with advanced non-small cell lung cancer previously treated with a cisplatin-based front line chemotherapy. Anticancer Res 22: 1891-1896, 2002.
24. Rocha-Lima CMS, Rizvi NA, Zhang K, Herndon JE, Crawford J, King GW and Green MR: CALGB 39809: Randomized phase II trial of gemcitabine/irinotecan and gemcitabine/docetaxel in stage IIIB (malignant pleural effusion) or stage IV NSCLC. Proc Am Soc Clin Oncol 21: 337a, 2002.
25. Kouroussis C, Agelidou A, Apostolopoulou F, Papakotoulas P, Ziotopoulos P, Georganta C, Anagnostopoulou O, Polyzos A, Androulakis N, Ginopoulos P and Georgoulias V: Second-line treatment with irinotecan (CPT-11) and gemcitabine (GEM) versus CPT-11 in patients with advanced NSCLC pretreated with taxanes and cisplatinum: preliminary results of a multicenter randomized phase II study. Proc Am Soc Clin Oncol 21: 304a, 2002.
26. Rosvold E, Langer CJ, Schilder R, Millenson M, Reimet E and Kreamer K: Salvage therapy with gemcitabine in (NSCLC) progressing after prior carboplatin-paclitaxel: Proc Am Soc Clin Oncol 17: 467a, 1998.
27. Guerra JA, Lianes P, Paz-Ares I et al: Efficacy and toxicity profile of gemcitabine in previously treated patients with advanced non-small cell lung cancer. Lung Cancer 18(Suppl 1): 28, 1997.
28. Garfield DH, Dakhil SR, Whittaker TL and Keller AM: Phase II randomized multicenter trial of two dose schedules of gemcitabine as second-line therapy in patients with advanced non-small cell lung cancer. Proc Am Soc Clin Oncol 17: 484a, 1998.
29. Gian V, Hainsworth JD, Burris HA, Erland JB, Brown CP, Rinaldi DA and Greco FA: Combination gemcitabine and vinorelbine in the second-line treatment of non-small cell lung cancer (NSCLC): A phase II study of the minnie pearl cancer research network. Proc Am Soc Clin Oncol 18: 505a, 1999.
30. Barr F, Mirsky H, Clinthorne D, Bendel S and Smith F: A phase III study of gemcitabine and vinorelbine salvage chemotherapy for taxane resistant non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 18: 496a, 1999.
31. Herbst RS, Khuri FR, Jung M, Fossella FV, Lee JS, Glisson B, Shin DM, Pisters K, Papadimitrakopoulou V, Kurie J, Perez-Soler R, Liu D, Munden R and Hong WK: Phase II study of combination weekly gemcitabine and vinorelbine in patients with untreated or previously treated non-small cell lung cancer. Proc Am Soc Clin Oncol 18: 462a, 1999.
32. Pectasides D, Kalofonos HP, Samantas E, Nicolaides C, Papacostas P, Onyenadum A, Visvikis A, Skarlos D and Fountzilas G: An out-patient second-line chemotherapy with gemcitabine and vinorelbine in patients with non-small cell lung cancer previously treated with cisplatin-based chemotherapy. A phase II study of the Hellenic Cooperative Oncology Group. Anticancer Res 21: 3005-3010, 2001.
33. Kosmas C, Tsavaris N, Panopoulos C, Vadiaka M, Stavroyianni N, Kourelis T, Malamos N, Antonopoulos M and Kalofonos HP: Gemcitabine and vinorelbine as second-line therapy in non-small cell lung cancer after prior treatment with taxane+platinum-based regimens. Eur J Cancer 37: 972-978, 2001.
34. Cao MG, Salgado E, Aramendia JM et al: Second line treatment with irinotecan (CPT-11) and navelbine (NVB) for non-small cell lung cancer (NSCLC) IIIB and IV disease. Proc Am Soc Clin Oncol 19: 540a, 2000.
35. Pectasides D, Fountzilas G, Rigopoulos A, Bountouroglou NG, Koutras A, Glotsos J, Onyenadum A, Makatsoris T and Kalofonos HP: Irinotecan and vinorelbine in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy. A phase II study of the Hellenic Cooperative Oncology Group. Anticancer Res 22: 3501-3506, 2002.
36. Abigerges D, Armand JP, Chabot GG, Da Costa L, Fadel E, Cote C, Herait P and Gandia D: Irinotecan (CPT-11) high-dose escalation using intensive high-dose loperamide to control diarrhea. J Natl Cancer Inst 86: 446-449, 1994.