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Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial

Information source: Gynecologic Oncology Trial & Investigation Consortium
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Intervention: Paclitaxel(intravenous) + Carboplatin(intravenous) (Drug); Paclitaxel(intravenous) + Carboplatin(intraperitoneal) (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Gynecologic Oncology Trial & Investigation Consortium

Official(s) and/or principal investigator(s):
Keiichi Fujiwara, MD, PhD, Study Chair, Affiliation: Saitama Medical University International Medical Center Comprehensive Cancer Center

Overall contact:
iPocc Trial Coordinating Center, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Summary

The purpose of this study is: Phase A: To confirm the feasibility of paclitaxel administered by intravenous (IV) infusion weekly plus concurrent carboplatin administered by intraperitoneal (IP) injection once every 3 weeks (dd-TCip therapy). Phase B: To compare the efficacy and safety of the following two treatment regimens as first-line chemotherapy in women with epithelial ovarian, Fallopian tube or primary peritoneal cancer.

Clinical Details

Official title: A Randomized Phase II/III Trial of Intravenous (IV) Paclitaxel Weekly Plus IV Carboplatin Once Every 3 Weeks Versus IV Paclitaxel Weekly Plus Intraperitoneal (IP) Carboplatin Once Every 3 Weeks in Women With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-free survival(PFS)

Secondary outcome:

Overall survival (OS)

Tumor response (only patients with evaluable disease)

Adverse events

Treatment completion rate

Quality of Life (QOL) assessments

Cost-utility analysis

Detailed description: This is a randomized, multicenter international study. Patient are stratified according to Residual tumor diameter([0cm(No residual)] vs. [0cm<residual<1cm] vs. [1cm2 cm]), FIGO stage(StageII vs. III vs. IV) and institution. Patient randomized to one of the treatment arms described below. RegimenI(Standard treatment: dd-TCiv therapy): Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks RegimenII(Study treatment: dd-TCip therapy): Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks The 3-week period (21 days) is 1 cycle. Protocol treatment basically comprises 6 cycles. IDS is allowed to be performed after 3, 4 or 5 cycles of the protocol treatment. In such cases, the protocol treatment must be restarted within 8 weeks after IDS. If IDS is performed, patients can receive up to 3 additional cycles of the protocol treatment after IDS. If interval debulking surgery (IDS) is performed after 3, 4 or 5 cycles, the patients can receive up to 3 additional cycles of the protocol treatment. A total of 6 to 8 cycles will be repeated. The analysis of efficacy will be performed on all randomized subjects in accordance with the intention-to-treat (ITT) principle. In order to assess the robustness of the results, the same analyses will be done using all randomized subjects who satisfy the eligibility criteria. The analysis of safety will be performed on all subjects who have received at least one dose of study treatment.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Patients assumed to have a stageII−IV epithelial ovarian, fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis 2. Patients scheduled to undergo laparotomy *Both optimal and suboptimal patients will be eligible for the study (Suboptimal patients, as well as those who undergo only exploratory laparotomy, are eligible.) 3. ECOG Performance Status: 0-2 4. Patients who provide consent for placement of the IP port system, if randomized to Regimen II (Study treatment: dd-TCip therapy) 5. Patients expected to receive the first protocol treatment within 8 weeks after the comprehensive staging surgery 6. Lab data and clinical examination: Data within 28 days before the scheduled date of surgery

- Neutrophil count ≧ 1,500 /mm3

- Platelet count ≧ 100,000 /mm3

- AST (GOT) ≦ 100 IU/L

- ALT (GPT) ≦ 100 IU/L

- Total bilirubin < 1. 5 mg/dL

- Serum Creatinine < 1. 5 mg/dL

- Electrocardiogram (ECG): Patients with normal ECG, Asymptomatic patients with

abnormal ECGs not requiring medical intervention

- Neuropathy(Both motor and sensory) ≦ Grade1 (CTCAE Version 4. 0)

7. Patients expected to survive longer than 3 months from the start date of the protocol treatment 8. Patients aged 20 years and older at the time of tentative registration (with no upper age limit) 9. Patients who provide written informed consent for participation in this trial Exclusion Criteria: 1. Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary peritoneal cancer 2. Patients who have received previous chemotherapy or radiation therapy to treat the current disease 3. Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with basal and squamous cell carcinoma of the skin, as well as carcinoma in situ, and intramucosal carcinoma cured by local treatment, are eligible for the study) 4. Patients with serious medical complications, such as serious heart disease, cerebrovascular accidents, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary fibrosis, interstitial pneumonitis, active bleeding, an active gastrointestinal ulcer, or a serious neurological disorder 5. Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil 6. Patients with a pleural effusion requiring continuous drainage 7. Patients with an active infection requiring antibiotics 8. Patients who are pregnant, nursing or of child-bearing potential 9. Patients with evidence upon physical examination of brain tumor and any brain metastases 10. Patients for whom completion of this study and/or follow-up is deemed inappropriate for any reason 11. Patients with any signs/symptoms of interstitial pneumonia

Locations and Contacts

iPocc Trial Coordinating Center, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Queen Mary Hospital, Pokfulam Road 102, Hong Kong; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

University Hospital, Kyoto Prefectural University of Medicine, Kyoto 602-0841, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

KK Women's and Children's Hospital, Bukit Timah 229899, Singapore; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

National University Hospital of Singapore, Lower Kent Ridge Road 119074, Singapore; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Aichi Cancer Center Hospital, Kanokoden, Chikusa-ku, Nagoya-shi, Aichi 464-0021, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Hirosaki University School of Medicine & Hospital, Hirosaki-shi, Aomori 036-8203, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

The Jikei University School of Medicine, Kashiwa Hospital, Kashiwashita, Kashiwa-shi, Chiba 277-8567, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

NHO Shikoku Cancer Center, Kou160 Minamiumemotomachi, Matsuyama-shi, Ehime 791-0245, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Ehime University Hospital, Toon-shi, Ehime 791-0204, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

University of Fukui Hospital, Matsuokashimoaizuki, Yoshida-gun, Eiheiji-cho, Fukui 910-1104, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

NHO Kyusyu Medical center, Jigyohama, Fukuoka-shi Chuo-ku, Fukuoka 810-8563, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Korea Cancer Center Hospital, Seoul, Gongneung-Dong 139-706, Korea, Republic of; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Gunma University Hospital, Showamachi, Maebashi-shi, Gunma 371-8511, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Gunma Prefectural Cancer Center, Takahayashinishicho, Ota-shi, Gunma 373-8550, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

NHO Kure Medical Center And Chugoku Cancer Center, Aoyamacho, Kure-shi, Hiroshima 737-0023, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Miyoshi Central Hospital, Higashisakeyamachi, Miyoshi-shi, Hiroshima 728-8502, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

JA Hiroshima General Hospital, Otemachi, Hiroshima-shi Naka-ku, Hiroshima 730-0051, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Hyogo Cancer Center, Akashi, Hyogo 673-0021, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Japanese Red Cross Society Himeji Hospital, Himeji, Hyogo 670-0063, Japan; Recruiting
Eriko Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Kobe City Medical Center General Hospital, Minatojimaminamimachi, Kobe-shi Chuo-ku, Hyogo 650-0047, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Hyogo Medical College Hospital, Mukogawacho, Nishinomiya-shi, Hyogo 663-8501, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Tsukuba University Hospital, Amakubo, Tsukuba-shi, Ibaraki 305-8576, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Iwate Medical University Hospital, Uchimaru, Morioka-shi, Iwate 020-8505, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Kagoshima City Hospital, Kajiyacho, Kagoshima-shi, Kagoshima 892-8580, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Yokohama Municipal Citizen's Hospital, Okazawacho, Yokohama-shi Hodogaya-ku, Kanagawa 240-8555, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Tokai University Hospital, Shimokasuya, Isehara-shi, Kanagawa 259-1143, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Mie University Hospital, Edobashi, Tsu-shi, Mie 514-8507, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Mie Prefectural General Medical Center, Hinaga, Yokkaichi-shi, Mie 510-8561, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Tohoku University Hospital, Seiryocho, Sendai-shi Aoba-ku, Miyagi 980-0872, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Shinshu University Hospital, Asahi, Matsumoto-shi, Nagano 390-0802, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Saiseikai Nagasaki Hospital, Katafuchi, Nagasaki-shi, Nagasaki 850-0003, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Nara Medical University Hospital, Shijocho, Kashihara-shi, Nara 634-8522, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Niigata University Medical & Dental Hospital, Asahimachidori, Niigata-shi Chuo-ku, Niigata 951-8520, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Niigata Cancer Center Hospital, Kawagishicho, Niigata-shi Chuo-ku, Niigata 951-8133, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Okinawa Prefectural Chubu Hospital, Miyazato, Uruma-shi, Okinawa 904-2293, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Osaka Medical College Hospital, Daigakumachi, Takatsuki-shi, Osaka 569-0801, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Kaizuka City Hospital, Hori, Kaizuka-shi, Osaka 597-0015, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Osaka Medical Center for Cancer and Cardiovascular Diseases, Nakamichi, Osaka-shi Higashinari-ku, Osaka 537-8511, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Osaka University Hospital, Yamadaoka, Suita-shi, Osaka 565-0871, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Saitama Medical University Saitama Medical Center, Kamoda, Kawagoe-shi, Saitama 350-8550, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Saitama Medical University International Medical Center, Yamane, Hidaka-shi, Saitama 350-1298, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Gangnam Severance Hospital in Korea, Seodaemun-gu, Seoul 250, Korea, Republic of; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Asan Medical Center, Songpa-gu, Seoul 138-736, Korea, Republic of; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Ewha Womans University Medical Center, Yangcheon-gu, Seoul 1071, Korea, Republic of; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Shizuoka Cancer Center, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Jichi Medical University Hospital, Yakushiji, Shimotsuke-shi, Tochigi 329-0498, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Tochigi Cancer Center, Yonan, Utsunomiya-shi, Tochigi 320-0834, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

The Cancer Institute Hospital Of JFCR, Ariake, Koto-ku, Tokyo 135-8550, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Juntendo University Hospital, Bunkyo, Tokyo 113-0033, Japan; Recruiting
Eriko Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Showa University Hospital, Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

The Jikei University Daisan Hospital, Izumihoncho, Komae-shi, Tokyo 201-8601, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Tokyo Women's Medical University Medical Center East, Kawadacho, Shinjuku-ku, Tokyo 162-0054, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

The Jikei University Hospital, Nishishinbashi, Minato-ku, Tokyo 105-8471, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Keio University Hospital, Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Tottori Municipal Hospital, Matoba, Tottori-shi, Tottori 680-0873, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Tottori University, Nishicho, Yonago-shi, Tottori 683-8504, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Yamaguchi University Hospital, Minamikogushi, Ube-shi, Yamaguchi 755-8505, Japan; Recruiting
Takaaki Takenaga, Phone: +81-3-5791-6419, Email: iPocc@insti.kitasato-u.ac.jp

Additional Information

Kitasato Academic Research Organization, Kitasato University

Japanese Gynecologic Oncology Group

Gynecologic Oncology Trial and Investigation Consortium [Japanese only]

Related publications:

Bristow RE, Tomacruz RS, Armstrong DK, Trimble EL, Montz FJ. Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: a meta-analysis. J Clin Oncol. 2002 Mar 1;20(5):1248-59.

Neijt JP, Engelholm SA, Tuxen MK, Sorensen PG, Hansen M, Sessa C, de Swart CA, Hirsch FR, Lund B, van Houwelingen HC. Exploratory phase III study of paclitaxel and cisplatin versus paclitaxel and carboplatin in advanced ovarian cancer. J Clin Oncol. 2000 Sep;18(17):3084-92.

Piccart MJ, Bertelsen K, James K, Cassidy J, Mangioni C, Simonsen E, Stuart G, Kaye S, Vergote I, Blom R, Grimshaw R, Atkinson RJ, Swenerton KD, Trope C, Nardi M, Kaern J, Tumolo S, Timmers P, Roy JA, Lhoas F, Lindvall B, Bacon M, Birt A, Andersen JE, Zee B, Paul J, Baron B, Pecorelli S. Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results. J Natl Cancer Inst. 2000 May 3;92(9):699-708.

Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, Mannel RS, DeGeest K, Hartenbach EM, Baergen R; Gynecologic Oncology Group. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2003 Sep 1;21(17):3194-200. Epub 2003 Jul 14.

Katsumata N, Yasuda M, Takahashi F, Isonishi S, Jobo T, Aoki D, Tsuda H, Sugiyama T, Kodama S, Kimura E, Ochiai K, Noda K; Japanese Gynecologic Oncology Group. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1331-8. doi: 10.1016/S0140-6736(09)61157-0. Epub 2009 Sep 18.

Alberts DS, Liu PY, Hannigan EV, O'Toole R, Williams SD, Young JA, Franklin EW, Clarke-Pearson DL, Malviya VK, DuBeshter B. Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer. N Engl J Med. 1996 Dec 26;335(26):1950-5.

Markman M, Bundy BN, Alberts DS, Fowler JM, Clark-Pearson DL, Carson LF, Wadler S, Sickel J. 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. 2001 Feb 15;19(4):1001-7.

Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43.

Miyagi Y, Fujiwara K, Kigawa J, Itamochi H, Nagao S, Aotani E, Terakawa N, Kohno I; Sankai Gynecology Study Group (SGSG). Intraperitoneal carboplatin infusion may be a pharmacologically more reasonable route than intravenous administration as a systemic chemotherapy. A comparative pharmacokinetic analysis of platinum using a new mathematical model after intraperitoneal vs. intravenous infusion of carboplatin--a Sankai Gynecology Study Group (SGSG) study. Gynecol Oncol. 2005 Dec;99(3):591-6. Epub 2005 Aug 10.

Fujiwara K, Armstrong D, Morgan M, Markman M. Principles and practice of intraperitoneal chemotherapy for ovarian cancer. Int J Gynecol Cancer. 2007 Jan-Feb;17(1):1-20. Review.

Demets DL. Futility approaches to interim monitoring by data monitoring committees. Clin Trials. 2006;3(6):522-9. Review.

Huang HQ, Brady MF, Cella D, Fleming G. Validation and reduction of FACT/GOG-Ntx subscale for platinum/paclitaxel-induced neurologic symptoms: a gynecologic oncology group study. Int J Gynecol Cancer. 2007 Mar-Apr;17(2):387-93.

Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, Siddik ZH, Judson IR, Gore ME, Wiltshaw E. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol. 1989 Nov;7(11):1748-56.

Starting date: May 2010
Last updated: March 17, 2015

Page last updated: August 23, 2015

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