Phase II study of fosfluridine tidoxil in an oral multiple dose schedule given once-a-day for 7 consecutive days every 2 weeks in patients with advanced breast and colorectal cancer

• Conditions: Patiens with confirmed metastatic breast or colorectal cancer. Breast:Pats should have received/failed at least 1 but no more than 2 lines of chemotherapy with taxanes and/or anthracyclines for metastatic disease. Colorectal:Pats not eligible for 1. chemotherapy of 5-FU with either oxaliplatin/irinotecan/bevacizumab. Pats are eligible if having received 1.line chemotherapy of 5-FU with either oxaliplatin/irinotecan/bevacizumab, but unable to tolerate >2 cycl. due to treatment-related toxicity

• Registration Number: EUCTR2005-001680-57-AT
• Lead Sponsor: Heidelberg Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-18
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- Patients with histologically or cytologically confirmed metastatic breast or colorectal cancer.
- At least one measurable lesion, as identified within the 4-week period prior to Screening (Visit 1 [Day -3 to -1]), which has not previously been irradiated.
Minimum measurable lesion size, in accordance with the RECIST criteria as measured at Screening (Visit 1 [Day -3 to -1]) or within the prior 4-week period :>= 10 mm measured by spiral computed tomography (CT) scan, or >= 20 mm measured by conventional CT scan.
- Male or female patients aged 18 years or older.
- Predicted life expectancy of >= 12 weeks as determined at Screening (Visit 1 [Day -3 to -1]), allowing adequate follow-up evaluation for toxicity and tumour response.
- Performance status of <= 2 on the ECOG scale
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients who received radiotherapy of one or more of the target lesions, within the 4 -week period prior to Screening (Visit 1 [Day 3 to -1]).
- Patients who are scheduled to receive planned radiotherapy during the planned Treatment Period or during follow-up.
- Patients who received more than 2 cycles of a 5-FU-containing combination chemotherapy in the treatment of metastatic colorectal cancer.
- Patients who have received 5-fluoropyrimidine-containing adjuvant treatment for colorectal cancer that was completed less than 12 months prior to Screening (Visit 1 [Day -3 to -1]).
- Patients who received more than two lines chemotherapy containing taxanes and/or anthracyclines in the treatment of metastatic breast cancer.
- Patients who have received neoadjuvant or adjuvant treatment for breast cancer that was completed less than 12 months prior to Screening (Visit 1 [Day -3 to -1]).
- Patients who received major surgery within the 4-week period prior to the first administration of study drug (Cycle 1 [Day 1]).
- Patients who received major surgery more than 4 weeks prior to the first administration of study drug (Cycle 1 [Day 1]), but who did not completely recover after surgery.
- Patients who received minor surgery within the 2-week period prior to the first administration of study drug (Cycle 1 [Day 1]).
- Patients who received radiotherapy or chemotherapy within the 4-week period prior to the first administration of study drug (Cycle 1 [Day 1]).
- Patients who received autologeous or allogeneic bone marrow transplantation at any time prior to Screening (Visit 1 [Day -3 to -1]).
Patients with known brain or meningeal metastases as determined at Screening (Visit 1 [Day -3 to -1]).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified