Phase I study of topotecan and radiation therapy in advanced cervical cancer.
OBJECTIVE
The goal of this study was to determine the maximal tolerated dose (MTD) of topotecan given with external-beam radiotherapy in advanced cervical cancer.


METHODS
A prospective Phase I trial of topotecan given with standard external-beam radiotherapy was performed in patients with advanced squamous cell carcinoma of the cervix. Patients were treated with a starting dose of 0.5 mg/m(2) and escalated by 0.25 mg/m(2). Nine patients were treated. Hematologic and nonhematologic toxicity were measured.


RESULTS
Patients were treated with 1.0 mg/m(2) daily for 5 days on Days 1-5 and 22-26 concomitantly with radiotherapy without significant toxicity. Grade III anemia in one case and Grade II leukopenia in two cases were seen in the three patients at this dose level. Dose-limiting toxicity was not reached.


CONCLUSIONS
Topotecan can be safely administered at a dose of 1.0 mg/m(2) during external-beam radiotherapy for advanced cervical cancer.
Dunton
Charles J
CJ
Division of Gynecologic Oncology, Jefferson Medical College, Philadelphia, Pennsylvania 19107, USA. charles.dunton@mail.tju.edu
King
Stephanie A
SA
Neufeld
Julia
J
Tolosa
Jorge
J
Perez
Gonzalo
G
Avila
Andres
A
Underhill
Kelly
K
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced / Q000209:etiology; D006801:Humans; D008875:Middle Aged; D011838:Radiation-Sensitizing Agents / Q000009:adverse effects* / Q000627:therapeutic use; D019772:Topotecan / Q000009:adverse effects* / Q000627:therapeutic use; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*
D000970:Antineoplastic Agents; D011838:Radiation-Sensitizing Agents; D019772:Topotecan