Phase I study of liposomal doxorubicin (Doxil) and cyclophosphamide in solid tumors

Investigational New Drugs

Volumn 23, Issue 1, 2005, Pages 57-62

  El Rayes, Basil F ^a   Ibrahim, Dina ^a   Shields, Anthony F ^a   Lorusso, Patricia M ^a   Zalupski, Mark M ^a   Philip, Philip A ^a  

^a WAYNE STATE UNIVERSITY   (United States)

Author keywords

Cyclophosphamide; Doxil; hand foot syndrome; Phase I

Indexed keywords

ANTIEMETIC AGENT; CYCLOPHOSPHAMIDE; DOXORUBICIN; LIPOSOME; ONDANSETRON;

ADULT; AGED; ALOPECIA; ANEMIA; ARTICLE; BLOOD TOXICITY; BONE MARROW; CARDIOTOXICITY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CORONARY ARTERY DISEASE; DRUG DOSE REDUCTION; DRUG FORMULATION; DRUG TOLERABILITY; DYSPNEA; ELECTROCORTICOGRAPHY; ERYTHEMA; ESOPHAGITIS; FEMALE; FIBROSARCOMA; HAND FOOT SYNDROME; HEART INFARCTION; HUMAN; KIDNEY CARCINOMA; KIDNEY FUNCTION; LIVER FUNCTION; LOW BACK PAIN; MALE; MUCOSA INFLAMMATION; NEUTROPENIA; PATIENT SELECTION; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR; STOMACH ADENOCARCINOMA; THORAX PAIN; THROMBOCYTOPENIA;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOPHOSPHAMIDE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOXORUBICIN; DRUG CARRIERS; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; LIPOSOMES; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS;

EID: 8644219670     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1023/B:DRUG.0000047106.20104.a7     Document Type: Article

References (15)

1. A'Hern RP, Smith IE, Ebbs SR: Chemotherapy and survival in advanced breast cancer: The inclusion of doxorubicin in Cooper type regimens. Br J Cancer 67: 801-805, 1993
2. Polychemotherapy for early breast cancer: An overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet 352: 930-942, 1998
3. Sparano JA, Winer EP: Liposomal anthracyclines for breast cancer. Semin Oncol 28: 32-40, 2001
4. Gabizon A, Catane R, Uziely B, Kaufman B, Safra T, Cohen R, Martin F, Huang A, Barenholz Y: Prolonged circulation time and enhanced accumulation in malignant exudates of doxorubicin encapsulated in polyethylene-glycol coated liposomes. Cancer Res 54: 987-992, 1994
5. Northfelt DW, Martin FJ, Working P, Volberding PA, Russell J, Newman M, Amantea MA, Kaplan LD: Doxorubicin encapsulated in liposomes containing surface-bound polyethylene glycol: Pharmacokinetics, tumor localization, and safety in patients with AIDS-related Kaposi's sarcoma. J Clin Pharmacol 36: 55-63, 1996
6. Uziely B, Jeffers S, Isacson R, Kutsch K, Wei-Tsao D, Yehoshua Z, Libson E, Muggia FM, Gabizon A: Liposomal doxorubicin: Antitumor activity and unique toxicities during two complementary phase I studies. J Clin Oncol 13: 1777-1785, 1995
7. Von Hoff DD, Layard MW, Basa P, Davis HL Jr, Von Hoff AL, Rozencweig M, Muggia FM: Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med 91: 710-717, 1979
8. Berry G, Billingham M, Alderman E, Richardson P, Torti F, Lum B, Patek A, Martin FJ: The use of cardiac biopsy to demonstrate reduced cardiotoxicity in AIDS Kaposi's sarcoma patients treated with pegylated liposomal doxorubicin. Ann Oncol 9: 711-716, 1998
9. Batist G, Ramakrishnan G, Rao CS, Chandrasekharan A, Gutheil J, Guthrie T, Shah P, Khojasteh A, Nair MK, Hoelzer K, Tkaczuk K, Park YC, Lee LW: Reduced cardiotoxicity and preserved antitumor efficacy of liposome - encapsulated doxorubicin and cyclophosphamide compared with conventional doxorubicin and cyclophosphamide in a randomized, multicenter trial of metastatic breast cancer. J Clin Oncol 19: 1444-1454, 2001
10. Vaage J, Donovan D, Wipff E, Abra R, Colbern G, Uster P, Working P: Therapy of a xenografted human colonie carcinoma using cisplatin or doxorubicin encapsulated in long-circulating pegylated stealth liposomes. Int J Cancer 80: 134-137, 1999
11. Ranson MR, Carmichael J, O'Byrne K, Stewart S, Smith D, Howell A: Treatment of advanced breast cancer with sterically stabilized liposomal doxorubicin: Results of a multicenter phase II trial. J Clin Oncol 15: 3185-3191, 1997
12. Holder L, Overmoyer B, Silverman P, Tripathy D, Marrs N: Doxil and oral cyclophosphamide as first line therapy for patients with metastatic breast cancer: Preliminary results of a pilot trial, ASCO proceedings 1, 1998
13. Silverman P, Overmoyer B, Holder L: Doxil and intravenous cyclophosphamide as first line therapy for patients with advanced breast cancer: Interim analysis of an ongoing pilot trial, ASCO proceeding 1, 1999
14. Slamon DJ, Godolphin W, Jones LA, Holt JA, Wong SG, Keith DE, Levin WJ, Stuart SG, Udove J, Ullrich A, Press MF: Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 244: 707-712, 1989
15. Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L: Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344: 783-792, 2001