Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer
NCT ID: NCT00220155
Last Updated: 2009-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2004-05-31
Brief Summary
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Detailed Description
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Treatment will continue until clinical indication due to PD or toxicity, or until completion of 6 cycles of gemcitabine, whichever comes first.
All patients will be assessed for toxicity and followed up for disease recurrence/progression.
The study will be divided into two accrual stages - the first consisting of 17 patients. If 6 or more patients achieve tumour response or stabilisation in the first stage, the second stage will commence accrual of a further 20 patients. Hence, the total planned accrual will be 37 patients.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Gemcitabine
Eligibility Criteria
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Inclusion Criteria
* Histologically proven colorectal adenocarcinoma.
* Locally advanced (inoperable) or metastatic colorectal carcinoma treated with at least one prior chemotherapy regimen.
* Progressive disease documented by CT either during or within 3 months of completion of previous chemotherapy
* No previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix.
* Unidimensional measurable disease as assessed by CT.
* Adequate bone marrow function; Hb \>10g/dl, platelets \>100 x109/l, WBC \>3x109/l, Neut \>1.5x109/l.
* Adequate liver function: Serum Bilirubin \<1.5 x upper limit of normal
* Adequate renal function: Serum Creatinine \< 0.11 mmol/L
* No concurrent uncontrolled medical conditions
* WHO performance status 0,1 or 2
* Adequate contraceptive precautions, if appropriate
* Informed written consent
* Negative pregnancy test in women of child bearing age
* Life expectancy \> 3 months
Exclusion Criteria
* Patients within 4 weeks of chemotherapy or radiotherapy (6 weeks for nitrosureas or mitomycin C).
* Previous treatment with gemcitabine.
* Patients with uncontrolled cerebral metastases.
18 Years
ALL
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Royal Marsden NHS Foundation Trust
Principal Investigators
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David Cunningham
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
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Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Countries
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Other Identifiers
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2398
Identifier Type: -
Identifier Source: org_study_id