Phase I clinical and pharmacological study of intraperitoneal cis-bis-neodecanoato(trans-R, R-1, 2-diaminocyclohexane)-platinum II entrapped in multilamellar liposome vesicles

Journal of Cancer Research and Clinical Oncology

Volumn 129, Issue 10, 2003, Pages 549-555

  Verschraegen, C F ^a,b   Kumagai, S ^b   Davidson, R ^b   Feig, B ^b   Mansfield, P ^b   Lee, S J ^b   Maclean, D S ^b   Hu, W ^b   Khokhar, A R ^b   Siddik, Z H ^b  

^a UNIVERSITY OF NEW MEXICO   (United States)

^b UNIVERSITY OF TEXAS   (United States)

Author keywords

Laparoscopy; Mesothelioma; Organoplatinum compounds; Peritoneal neoplasms

Indexed keywords

LIPOSOME; PLATINUM 1,2 DIAMINOCYCLOHEXANE BISNEODECANOATE; TECHNETIUM SULFUR COLLOID TC 99M;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; ASCITES; BACKACHE; BLOOD TOXICITY; CARCINOMATOUS PERITONITIS; CATHETERIZATION; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; COLON ADENOCARCINOMA; COLON PERFORATION; CONSTIPATION; COUGHING; DIARRHEA; DISORIENTATION; DRUG ABSORPTION; DRUG DELIVERY SYSTEM; DRUG DISTRIBUTION; DRUG FORMULATION; DYSPEPSIA; DYSPNEA; FATIGUE; FEMALE; FIBROSIS; GASTROINTESTINAL TUMOR; GRANULOCYTOPENIA; HEMATOMA; HICCUP; HUMAN; HYDROCELE; HYPOALBUMINEMIA; INFLAMMATION; LEG EDEMA; LEUKOCYTOSIS; MALE; MALIGNANT MESOTHELIOMA; NAUSEA; NEUTROPENIA; OVARY CARCINOMA; PERITONEUM ADHESION; PERITONEUM PSEUDOMYXOMA; PERITONITIS; PEROPERATIVE COMPLICATION; PHASE 1 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; SARCOMA; SIDE EFFECT; SIGNET RING CARCINOMA; THROMBOCYTOPENIA; WEIGHT REDUCTION;

ADENOCARCINOMA; ADULT; AGED; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; ASCITES; CARCINOMA, SIGNET RING CELL; COLORECTAL NEOPLASMS; ENDOMETRIAL STROMAL TUMORS; FEMALE; HUMANS; INJECTIONS, INTRAPERITONEAL; LIPOSOMES; MALE; MESOTHELIOMA; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; OVARIAN NEOPLASMS; PERITONEAL NEOPLASMS; PERITONEUM; TECHNETIUM; TISSUE DISTRIBUTION;

EID: 0242266387     PISSN: 01715216     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00432-003-0481-3     Document Type: Article

References (29)

1. Fujimoto S, Takahashi M, Mutou T, Kobayashi K, Toyosawa T, Isawa E, Sumida M, Ohkubo H (1997) Improved mortality rate of gastric carcinoma patients with peritoneal carcinomatosis treated with intraperitoneal hyperthermic chemoperfusion combined with surgery. Cancer 79:884
2. Griffiths CT, Fuller AF (1978) Intensive surgical and chemotherapeutic management of advanced ovarian cancer. Surg Clin North Am 58:131
3. Jacquet P, Stephens AD, Averbach AM, Chang D, Ettinghausen SE, Dalton RR, Steves MA, Sugarbaker PH (1996) Analysis of morbidity and mortality in 60 patients with peritoneal carcinomatosis treated by cytoreductive surgery and heated intraoperative intraperitoneal chemotherapy. Cancer 77:2622
4. Sugarbaker PH, Zhu BW, Sese GB, Shmookler B (1993) Peritoneal carcinomatosis from appendiceal cancer: results in 69 patients treated by cytoreductive surgery and intraperitoneal chemotherapy. Dis Colon Rectum 36:323
5. Sugarbaker PH, Jablonski KA (1995) Prognostic features of 51 colorectal and 130 appendiceal cancer patients with peritoneal carcinomatosis treated by cytoreductive surgery and intraperitoneal chemotherapy (comments). Ann Surg 221:124
6. Markman M, Bundy BN, Alberts DS, Fowler JM, Clark-Pearson DL, Carson LF, Wadler S, Sickel J (2001) Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group. J Clin Oncol 19:1001
7. Alberts DS, Liu PY, Hannigan EV, O'Toole R, Williams SD, Young JA, Franklin EW, Clarke-Pearson DL, Malviya VK, DuBeshter B (1996) Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer (comments). N Engl J Med 335:1950
8. Armstrong DK, Bundy BN, Baergen R, Lele SB, Copeland LJ, Walker J, Burger R (2002) Randomized phase III study of intravenous (IV) paclitaxel and cisplatin versus IV paclitaxel, intraperitoneal (IP) cisplatin and IP paclitaxel in optimal stage III epithelial ovarian cancer (OC): a Gynecologic Oncology Group trial (GOG 172). A803
9. Fujimura T, Yonemura Y, Fushida S, Urade M, Takegawa S, Kamata T, Sugiyama K, Hasegawa H, Katayama K, Miwa K (1990) Continuous hyperthermic peritoneal perfusion for the treatment of peritoneal dissemination in gastric cancers and subsequent second-look operation. Cancer 65:65
10. Esquivel J, Vidal-Jove J, Steves MA, Sugarbaker PH (1993) Morbidity and mortality of cytoreductive surgery and intraperitoneal chemotherapy (comments). Surgery 113:631
11. Perez-Soler R, Shin DM, Siddik ZH, Murphy WK, Huber M, Lee SJ, Khokhar AR, Hong WK (1997) Phase I clinical and pharmacological study of liposome-entrapped NDDP administered intrapleurally in patients with malignant pleural effusions. Clin Cancer Res 3:373
12. Siddik ZH, Boxall FE, Harrap KR (1987) Flameless atomic absorption spectrophotometric determination of platinum in tissues solubilized in hyamine hydroxide. Anal Biochem 163:21
13. Perez-Soler R, Lopez-Berestein G, Lautersztain J, al-Baker S, Francis K, Macias-Kiger D, Raber MN, Khokhar AR (1990) Phase I clinical and pharmacological study of liposome-entrapped cis-bis-neodecanoato-trans-R,R-1,2- diaminocyclohexane platinum(ii). Cancer Res 50:4254
14. Alberts DS, Markman M, Armstrong D, Rothenberg ML, Muggia F, Howell SB (2002) Intraperitoneal therapy for stage III ovarian cancer: a therapy whose time has come! J Clin Oncol 20:3944
15. Koga S, Hamazoe R, Maeta M, Shimizu N, Murakami A, Wakatsuki T (1988) Prophylactic therapy for peritoneal recurrence of gastric cancer by continuous hyperthermic peritoneal perfusion with mitomycin C. Cancer 61:232
16. Hamazoe R, Maeta M, Kaibara N (1994) Intraperitoneal thermochemotherapy for prevention of peritoneal recurrence of gastric cancer. Final results of a randomized controlled study. Cancer 73:2048
17. Speyer JL (1985) The rationale behind intraperitoneal chemotherapy in gastrointestinal malignancies. Semin Oncol 12:23
18. Markman M (1994) Intraperitoneal cisplatin and carboplatin in the management of ovarian cancer. Semin Oncol 21:17
19. Lind M, Murphy D, Sharma H, Tinker N, Smith A, McAuliffe C, Crowther D (1991) Comparative intraperitoneal pharmacokinetics of three platinum analogues. Cancer Chemother Pharmacol 28:315
20. Elferink F, Vijgh WVD, Klein I, Huinink WTB, Dubbelman R, McVie J (1988) Pharmacokinetics of carboplatin after intraperitoneal administration. Cancer Chemother Pharmacol 21:57
21. Marchettini P, Stuart OA, Mohamed F, Yoo D, Sugarbaker PH (2002) Docetaxel: pharmacokinetics and tissue levels after intraperitoneal and intravenous administration in a rat model. Cancer Chemother Pharmacol 49:499
22. Gelderblom H, Verweij J, van Zomeren DM, Buijs D, Ouwens L, Nooter K, Stoter G, Sparreboom A (2002) Influence of Cremophor El on the bioavailability of intraperitoneal paclitaxel. Clin Cancer Res 8:1237
23. Francis P, Rowinsky E, Schneider J, Hakes T, Hoskins W, Markman M (1995) Phase I feasibility and pharmacologic study of weekly intraperitoneal paclitaxel: a Gynecologic Oncology Group pilot study. J Clin Oncol 13:2961
24. Perez-Soler R, Francis K, al-Baker S, Pilkiewicz F, Khokhar AR (1994) Preparation and characterization of liposomes containing a lipophilic cisplatin derivative for clinical use. J Microencapsul 11:41
25. Khokhar AR, al-Baker S, Brown T, Perez-Soler R (1991) Chemical and biological studies on a series of lipid-soluble (trans-(R,R)-and -(S,S)-1,2-diaminocyclohexane)platinum(II) complexes incorporated in liposomes. J Med Chem 34:325
26. Perez-Soler R, Yang LY, Drewinko B, Lauterzstain J, Khokhar AR (1988) Increased cytotoxicity and reversal of resistance to cis-diamminedichloro- platinum(ii) with entrapment of cis-bis-neodecanoato-trans-R,R-1,2- diaminocyclohexaneplatinum (ii) in multilamellar lipid vesicles. Cancer Res 48:4509
27. Perez-Soler R, Lautersztain J, Stephens LC, Wright K, Khokhar AR (1989) Preclinical toxicity and pharmacology of liposome-entrapped cis-bis- neodecanoato-trans-R,R-1 ,2-diaminocyclohexane platinum(II). Cancer Chemother Pharmacol 24:1
28. Yonemura Y, de Aretxabala X, Fujimura T, Fushida S, Katayama K, Bandou E, Sugiyama K, Kawamura T, Kinoshita K, Endou Y, Sasaki T (2001) Intraoperative chemohyperthermic peritoneal perfusion as an adjuvant to gastric cancer: final results of a randomized controlled study. Hepatogastroenterology 48:1776
29. Elias DM, Ouellet JF (2001) Intraperitoneal chemohyperthermia: rationale, technique, indications, and results. Surg Oncol Clin North Am 10:915