A Phase-II Study Of TOMUDEX Plus Radiotherapy In Subject With Inoperable or Recurrent Rectal Cancer

AstraZeneca1 site in 1 country49 target enrollmentAugust 2002

ConditionsInoperable or Recurrent Rectal Cancer

DrugsTomudex

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Inoperable or Recurrent Rectal Cancer
Sponsor: AstraZeneca
Enrollment: 49
Locations: 1
Primary Endpoint: This study will evaluate the value of TOMUDEX in combination with a 'standard' course of pelvic radiotherapy for inoperable/recurrent rectal cancer, in terms of response rate and increasing the resectability rate
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The pilot study is designed to investigate the value of Neo-adjuvant Tomudez in combination with radiotherapy in patients with inoperable or recurrent rectal cancer in terms of response rate and increasing the resectability of initially inoperable rectal cancer.

Registry

clinicaltrials.gov

Start Date

August 2002

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Confirmed diagnosis of inoperable/recurrent rectal cancer
•Age \> 18 years
•At least 1 measurable lesion should be present
•WHO performance score \< 2
•Life expentancy of at least 12 weeks
•Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
•Documented informed consent to participate in the trial

Exclusion Criteria

•Previous systemic chemotherapy
•Previous radiotherapy to the planned exposure area
•Subjects with distant metastases
•(a)white blood cell \< 4.0x109/L (unless absolute neutrophil count is \>2.0x109/L or (b) Platelet count \< 100x109/L
•Serum creatinine above the upper limit of the normal range
•(a) Serum bilirubin \> 1.25 times the upper limit of the normal range or (b) Asparate aminotransferase(AST) or Alanine amiontransferase (ALT) \>2.5 times the upper limit of the normal range
•Any severe concurrent medical condition which would make it undesirable, in the clinician's opinion, for the patient to participate in the trial or which would jeopardise compliance with the trial period
•Pregnancy or breast feeding. Women of childbearing age must use effective contraception
•Previous or current malignancies at other sites, with the exception of adequately treated in-situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
•Patient participation in other studies

Outcomes

Primary Outcomes

This study will evaluate the value of TOMUDEX in combination with a 'standard' course of pelvic radiotherapy for inoperable/recurrent rectal cancer, in terms of response rate and increasing the resectability rate