Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

NCT00158886 | Terminated Phase 1

• 1 other identifier: 104864/517
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Renal Cell

Keywords

oral topotecan rectal cancer pelvic radiation

Outcome Measures

Primary Outcomes (1)

• To determine the MTD of oral topotecan in combination with pelvic radiation

  Up to 24 months

Secondary Outcomes (1)

• 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

Study Arms (1)

Subjects with rectal cancer

EXPERIMENTAL

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.

Drug: Topotecan; Radiation: Radiation therapy

Interventions

Topotecan DRUG

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

Also known as: Hycamtin

Subjects with rectal cancer

Radiation therapy RADIATION

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 \[mv\]).

Subjects with rectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Tampa, Florida, 33612-9497, United States

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Topotecan; Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Therapeutics

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: November 8, 2001
• Primary Completion: August 11, 2006
• Study Completion: August 11, 2006
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

US (1)