Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT00158886|
Recruitment Status : Terminated
First Posted : September 12, 2005
Last Update Posted : November 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Renal Cell||Drug: Topotecan Radiation: Radiation therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer|
|Actual Study Start Date :||November 8, 2001|
|Actual Primary Completion Date :||August 11, 2006|
|Actual Study Completion Date :||August 11, 2006|
Experimental: Subjects with rectal cancer
Subjects will be administered topotecan along with concomitant radiation for five days per week for five weeks. Topotecan doses will start at 0.25 milligrams per square meter (mg/m˄2) and will be escalated 0.15 mg/m˄2 for subsequent cohorts. To advance to the next dose level of topotecan, at least two subjects will have to complete therapy with oral topotecan without experiencing grade 3 or 4 toxicity for three weeks after the oral topotecan treatment.
Topotecan will be provided as capsules for oral administration and will be administered at least 3 hours before radiation therapy.
Other Name: Hycamtin
Radiation: Radiation therapy
For radiation therapy, subjects will receive 180 centigray (cGy) per fraction to a total dose of 4500 cGy to the pelvis using a 3 or 4 field technique and high energy photons (>=6 megavolt [mv]).
- To determine the MTD of oral topotecan in combination with pelvic radiation [ Time Frame: Up to 24 months ]
- To evaluate the toxicity and potential efficacy of oral topotecan and concurrent pelvic radiation for the treatment of rectal cancer. To determine pathologic response to treatment and assessment of sphincter preservation. [ Time Frame: Up to 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158886
|United States, Florida|
|GSK Investigational Site|
|Tampa, Florida, United States, 33612-9497|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|