None listed
Conditions
Brief summary
The aim of this study was to compare the response rate (RR), progression free survival (PFS) and overall survival (OS) and to assess the toxicity profile of previously untreated patients with advanced colorectal cancer (CRC) randomly assigned between Camptothecin-11 (CPT-11)/5FU /Folinic Acid (arm A) versus Camptothecin-11 (CPT-11)/Fluorouracil (5FU)/Folinic Acid followed by Oxaliplatin/Fluorouracil (5FU)/Folinic Acid(arm B) in the same line of treatment. A theoretical framework supports the hypothesis that the sequential administration of cytotoxic drugs at adequate doses can maximize the cell kill and overcome drug resistance.
Interventions
CPT-11+ Folinic Acid+ 5FU weekly for 6 weeks on days 1,8,15,22,29 and 36 (followed by 2 weeks rest for a total cycle duration of 8 weeks) at the following doses:
CPT-11: 80 mg/m2 in 250 ml normal saline intravenous injection (IV) over 90 minutes
Folinic acid: 200 mg/m2 in 500 ml normal saline IV over 2 hours
5FU: 450 mg/m2 IV bolus.
This 8-week cycle will be administered in an identical manner again (i.e. total 16 weeks).
Then, it will be followed by Oxaliplatin+ Folinic Acid+ 5FU weekly for
CPT-11+ Folinic Acid+ 5FU weekly for 6 weeks on days 1,8,15,22,29 and 36 (followed by 2 weeks rest for a total cycle duration of 8 weeks) at the following doses: CPT-11: 80 mg/m2 in 250 ml normal saline intravenous injection (IV) over 90 minutes Folinic acid: 200 mg/m2 in 500 ml normal saline IV over 2 hours 5FU: 450 mg/m2 IV bolus. This 8-week cycle will be administered in an identical manner again (i.e. total 16 weeks). Then, it will be followed by Oxaliplatin+ Folinic Acid+ 5FU weekly for 6 weeks on days 1,8,15,22,29 and 36 (followed by 2 weeks rest for a total cycle duration of 8 weeks) at the following doses: Oxaliplatin: 45 mg/m2 IV over a 90 min infusion Folinic acid: 200 mg/m2 in 500 ml normal saline IV over 2 hours 5FU: 450 mg/m2 IV bolus This 8-week cycle will be administered in an identical manner again (i.e. total 16 weeks). The overall duration of the intervention will be 32 weeks in total (4 cycles).
Sponsors
Hellenic Cooperative Oncology Group (HeCOG)
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
INCUSION CRITERIA Histologically confirmed metastatic adeno-carcinoma of the colon or rectum. Measurable metastatic disease (at least one) bidimensionally measurable lesion [according to WHO (World Health Organization) criteria]. No potentailly resectable metastasis. Patients should be over 18 years old. WHO/ECOG (Eastern Cooperative Oncology Group) performance status 0-2. No prior chemotherapy or only adjuvant chemotherapy ended more than 6 months before randomisation. Adequate renal and liver function creatinine <= 1.5 x upper normal limits, Serum glutamic oxaloacetic transaminase (SGOT)/Serum glutamic pyruvic transaminase (SGPT) <=5 x upper normal limits). Baseline neutrophil count > 1,500/iL and platelet count > 100,000/iL.
Exclusion criteria
EXCLUSION CRITERIA Pregnant or lactating patients. Patients with reproductive potential who are not using adequate contraceptive measures. Any prior chemotherapy for advanced disease. Adjuvant treatment ended within 6 months preceding study entry. Central Nervous System (CNS) metastases, bone metastases or serosal effusions as the sole indicate of tumour. Current history of chronic diarrhea. Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix. Other serious illness (recent history of myocardial infarction, < 6 months).
Outcome results
None listed