Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Topotecan

Radiation therapy

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring oral topotecan rectal cancer pelvic radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects with rectal cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00158886

First Posted

September 8, 2005

Last Updated

November 10, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00158886

Brief Title

Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Terminated

Study Start Date

November 8, 2001 (Actual)

Primary Completion Date

August 11, 2006 (Actual)

Study Completion Date

August 11, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Renal Cell

Keywords

oral topotecan rectal cancer pelvic radiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects with rectal cancer

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Topotecan

Other Intervention Name(s)

Hycamtin

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Radiation therapy

Intervention Description

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]).

Primary Outcome Measure Information:

Title

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

Time Frame

Up to 24 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612-9497

Country

United States

Carcinoma, Renal Cell

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial