Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

Carcinoma, Renal Cell Clinical Trial

Official title:

A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00158886
• Other study ID #: 104864/517
• Status: Terminated
• Phase: Phase 1
• First received: September 8, 2005
• Last updated: November 10, 2017
• Start date: November 8, 2001
• Est. completion date: August 11, 2006

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with rectal cancer who are candidates for pre-operative radiation therapy may be enrolled in the Phase I, single center study. Patients will have a full blood count, biochemistry, urinalysis, and ECG for safety evaluation. Sequential cohorts of three patients will be given increasing doses of oral topotecan and fixed doses of concurrent radiation (45 Gy) over five weeks. The starting dose of oral topotecan is 0.25 mg/m2 to be concomitantly administered with radiation (45 Gy) x 5 days every week unless the radiation is interrupted for Holidays/Weekends or toxicity requiring treatment delays occurs. A total of 25 doses are planned.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: August 11, 2006
• Est. primary completion date: August 11, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with histologically confirmed rectal cancer.

• Candidates for preoperative radiotherapy.

• Primary tumor at least 3cm and clinical stage of T2, T3, or T4 and any N according to the Astler-Coller modification of the Dukes staging system.

• Eastern Cooperative Oncology Group (ECOG) performance status less than 2.

• Diagnosis of rectal cancer should be no more than 90 days from start of therapy.

• Evaluation at the H. Lee Moffitt Cancer Center.

• Recovery from prior surgery and life expectancy at least 3 months.

Exclusion Criteria:

• A primary tumor totally excised.

• Recurrent rectal cancer that failed initial treatment.

• Exposure to topotecan, infection, immunodeficiencies, conditions of the gastrointestinal (GI) tract which would affect absorption, medication that maintains motility/gastric emptying.

• Any concomitant malignancy within the last five years.

• Severe medical problems unrelated to the malignancy which would limit compliance with the study.

• Patients of child bearing potential.

• Not practicing adequate contraception.

• Patients who are pregnant or lactating.

• Use of an investigational drug within 30 days or 5 half-lives of the first dose.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Rectal Neoplasms

Intervention

Drug:
• Topotecan
Topotecan will be provided as capsules for oral administration and will be administered at least 3 hours before radiation therapy.

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]).

Locations

Country	Name	City	State
United States	GSK Investigational Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the MTD of oral topotecan in combination with pelvic radiation		Up to 24 months
Secondary	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.		Up to 24 months

External Links

•   Results for study 104864/517 can be found on the GSK Clinical Study Register.