BIOMAT Database Logo BIOMAT Database Logo

A phase I trial of gemcitabine and topotecan in previously treated ovarian or peritoneal cancer: a Gynecologic Oncology Group study. 2006

M Dwight Chen, and Gini F Fleming, and Suann Mitchell, and Ira Horowitz
Center for Gynecologic Oncology and Pelvic Surgery, 815 Pollard Road, Los Gatos, CA 95032, USA. chenmd@sbcglobal.net

OBJECTIVE To determine the maximum tolerated dose (MTD) of the combination of gemcitabine and topotecan in women with previously treated epithelial ovarian, peritoneal, or fallopian tube cancer. METHODS Patients with recurrent or persistent cancer after treatment with a platinum and paclitaxel-containing regimen were eligible for this study. Initial treatment was gemcitabine at a dose of 800 mg/m(2) on days 1, 8, and 15 and topotecan at a dose of 0.5 mg/m(2) on days 2-5, with cycles repeated every 28 days. Dose escalations were planned first for topotecan (Cohort I, Dose Levels 1-5) then for gemcitabine (Cohort II, Dose Levels 6-9) until the MTD was reached. RESULTS Ten patients received a total of 29 cycles. When none of the first four patients could complete therapy as prescribed due to toxicity, doses for each drug were reduced by 1 day. The next six patients were treated at the modified schedule of gemcitabine days 1 and 8 and topotecan days 2-4 (Dose Level -1). Despite this modification, dose-limiting toxicities including neutropenia, thrombocytopenia, and stomatitis occurred at Dose Level -1, and the study was closed early. CONCLUSIONS At both the initial dose schedule and an attenuated schedule, the combination of gemcitabine and topotecan produced dose-limiting toxicities in women with previously treated epithelial ovarian or peritoneal cancer.

UI MeSH Term Description Entries
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009364 Neoplasm Recurrence, Local The local recurrence of a neoplasm following treatment. It arises from microscopic cells of the original neoplasm that have escaped therapeutic intervention and later become clinically visible at the original site. Local Neoplasm Recurrence,Local Neoplasm Recurrences,Locoregional Neoplasm Recurrence,Neoplasm Recurrence, Locoregional,Neoplasm Recurrences, Local,Recurrence, Local Neoplasm,Recurrence, Locoregional Neoplasm,Recurrences, Local Neoplasm,Locoregional Neoplasm Recurrences,Neoplasm Recurrences, Locoregional,Recurrences, Locoregional Neoplasm
D010051 Ovarian Neoplasms Tumors or cancer of the OVARY. These neoplasms can be benign or malignant. They are classified according to the tissue of origin, such as the surface EPITHELIUM, the stromal endocrine cells, and the totipotent GERM CELLS. Cancer of Ovary,Ovarian Cancer,Cancer of the Ovary,Neoplasms, Ovarian,Ovary Cancer,Ovary Neoplasms,Cancer, Ovarian,Cancer, Ovary,Cancers, Ovarian,Cancers, Ovary,Neoplasm, Ovarian,Neoplasm, Ovary,Neoplasms, Ovary,Ovarian Cancers,Ovarian Neoplasm,Ovary Cancers,Ovary Neoplasm
D010534 Peritoneal Neoplasms Tumors or cancer of the PERITONEUM. Peritoneal Carcinomatosis,Peritoneal Surface Malignancy,Carcinomatosis, Peritoneal,Malignancy, Peritoneal Surface,Neoplasm, Peritoneal,Peritoneal Carcinomatoses,Peritoneal Neoplasm,Peritoneal Surface Malignancies,Surface Malignancy, Peritoneal
D003841 Deoxycytidine A nucleoside component of DNA composed of CYTOSINE and DEOXYRIBOSE. Cytosine Deoxyribonucleoside,Cytosine Deoxyriboside,Deoxyribonucleoside, Cytosine,Deoxyriboside, Cytosine
D004305 Dose-Response Relationship, Drug The relationship between the dose of an administered drug and the response of the organism to the drug. Dose Response Relationship, Drug,Dose-Response Relationships, Drug,Drug Dose-Response Relationship,Drug Dose-Response Relationships,Relationship, Drug Dose-Response,Relationships, Drug Dose-Response
D005185 Fallopian Tube Neoplasms Benign or malignant neoplasms of the FALLOPIAN TUBES. They are uncommon. If they develop, they may be located in the wall or within the lumen as a growth attached to the wall by a stalk. Cancer of the Fallopian Tube,Fallopian Tube Cancer,Cancer, Fallopian Tube,Cancers, Fallopian Tube,Fallopian Tube Cancers,Fallopian Tube Neoplasm,Neoplasm, Fallopian Tube,Neoplasms, Fallopian Tube
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000093542 Gemcitabine A deoxycytidine antimetabolite used as an antineoplastic agent. 2',2'-Difluoro-2'-Deoxycytidine,2',2'-Difluorodeoxycytidine,2'-Deoxy-2',2''-Difluorocytidine-5'-O-Monophosphate,2'-Deoxy-2'-Difluorocytidine,Gemcitabine Hydrochloride,Gemcitabine, (D-threo-pentafuranosyl)-Isomer,Gemcitabine, (alpha-D-threo-pentofuranosyl)-Isomer,Gemcitabine, (beta-D-threo-pentafuranosyl)-Isomer,Gemicitabine,2',2'-DFDC,Gemzar,LY 188011,LY-188011,dFdCyd,188011, LY,2' Deoxy 2' Difluorocytidine,2' Deoxy 2',2'' Difluorocytidine 5' O Monophosphate,Hydrochloride, Gemcitabine

Related Publications

M Dwight Chen, and Gini F Fleming, and Suann Mitchell, and Ira Horowitz
Phase I feasibility trial of carboplatin, paclitaxel, and gemcitabine in patients with previously untreated epithelial ovarian or primary peritoneal cancer: a Gynecologic Oncology Group study.
January 2004, Gynecologic oncology,
M Dwight Chen, and Gini F Fleming, and Suann Mitchell, and Ira Horowitz
Phase I trial and pharmacologic trial of sequences of paclitaxel and topotecan in previously treated ovarian epithelial malignancies: a Gynecologic Oncology Group study.
January 1997, Journal of clinical oncology : official journal of the American Society of Clinical Oncology,
M Dwight Chen, and Gini F Fleming, and Suann Mitchell, and Ira Horowitz
A phase II trial of edatrexate in previously treated ovarian cancer. A Gynecologic Oncology Group study.
April 1995, American journal of clinical oncology,
M Dwight Chen, and Gini F Fleming, and Suann Mitchell, and Ira Horowitz
Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: a phase II study of the Gynecologic Oncology Group.
November 2006, Gynecologic oncology,
M Dwight Chen, and Gini F Fleming, and Suann Mitchell, and Ira Horowitz
Phase II multicenter open-label study of karenitecin in previously treated epithelial ovarian and primary peritoneal cancer: a Gynecologic Oncology Group Study.
January 2008, International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,
M Dwight Chen, and Gini F Fleming, and Suann Mitchell, and Ira Horowitz
Phase II trial of bevacizumab in persistent or recurrent epithelial ovarian cancer or primary peritoneal cancer: a Gynecologic Oncology Group Study.
November 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology,
M Dwight Chen, and Gini F Fleming, and Suann Mitchell, and Ira Horowitz
Sequential prolonged oral topotecan and prolonged oral etoposide as second-line therapy in ovarian or peritoneal carcinoma: a phase I Gynecologic Oncology Group study.
August 2006, Gynecologic oncology,
M Dwight Chen, and Gini F Fleming, and Suann Mitchell, and Ira Horowitz
A phase II trial of gallium nitrate (NSC #15200) in previously treated ovarian carcinoma. A Gynecologic Oncology Group Study.
August 1991, American journal of clinical oncology,
M Dwight Chen, and Gini F Fleming, and Suann Mitchell, and Ira Horowitz
A phase II trial of paclitaxel poliglumex in recurrent or persistent ovarian or primary peritoneal cancer (EOC): a Gynecologic Oncology Group Study.
December 2008, Gynecologic oncology,
M Dwight Chen, and Gini F Fleming, and Suann Mitchell, and Ira Horowitz
A phase II trial of Didemnin B (NSC #335319) in patients with previously treated epithelial ovarian cancer. A Gynecologic Oncology Group Study.
February 1993, American journal of clinical oncology,
Copied contents to your clipboard!