Clinical Trials Logo
  1. Home
  2. Metastatic Colorectal Cancer
  3. NCT00233623
  4. Details
NCT00233623 Clinical Trial

Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title:
A Randomised, Non-Comparative, Multicentre, Phase II, Parallel-Group Trial Of ZD1839 (Iressa™) In Combination With 5 Fluorouracil, Leucovorin And Cpt-11 (Irinotecan) In Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00233623
Other study ID # 1839IL/0138
Secondary ID
Status Withdrawn
Phase Phase 2
First received October 4, 2005
Last updated January 25, 2011
Start date July 2004
Est. completion date January 2006

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

The aim of the study is to determine if Iressa added to chemotherapy with Irinotecan, 5Fluorouracil and Leucovorin can prolong the period of time without any disease worsening (Time to Progression) in patients with metastatic colorectal cancer.

Recruitment information / eligibility
Status Withdrawn
Enrollment 190
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically confirmed metastatic colorectal cancer

- Presence of measurable metastases

- No previous treatment for metastatic cancer

Exclusion Criteria:

- No presence of Central Nervous System metastases

- No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ

- Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Iressa (Gefitinib)

• Irinotecan

• 5Fluorouracil

• Leucovorin

Locations
Country Name City State
Italy Research Center Bari
Italy Research Site Bergamo
Italy Research Site Catania
Italy Research Site Cremona
Italy Research Site Cuneo
Italy Research Site L'Aquila
Italy Research Site La Spezia
Italy Research Site Milano
Italy Research Site Palermo
Italy Research Site Pescara
Italy Research Site Rozzano
Italy Research Site Torino
Italy Research Site Venezia

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to progression (6 months after Last patient in)
Secondary Objective Response Rate, Duration of Response, Disease control rate, Overall Survival, (6 months after Last patient in)
See also
  Status Clinical Trial Phase
Completed NCT01228734 - A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients Phase 3
Completed NCT05178745 - A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
Completed NCT01591421 - P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Metastatic/Advanced RAS-Wild Type Colorectal Cancer. Phase 1/Phase 2
Withdrawn NCT05412706 - Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy Phase 2
Withdrawn NCT04430985 - FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer Phase 2
Withdrawn NCT03182894 - Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer Phase 1/Phase 2
Recruiting NCT05725200 - Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer Phase 2
Terminated NCT03176264 - PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer Phase 1
Completed NCT04866290 - HepaSphere™ Microspheres Prospective Registry
Not yet recruiting NCT06425133 - Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers Phase 2
Not yet recruiting NCT05531045 - 18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
Withdrawn NCT03982173 - Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors Phase 2
Completed NCT02906059 - Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer Phase 1
Active, not recruiting NCT02575378 - Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer Phase 4
Withdrawn NCT02535988 - Abscopal Effect for Metastatic Colorectal Cancer Phase 2
Recruiting NCT02848807 - Chemotherapy-related Toxicity, Nutritional Status and Quality of Life N/A
Active, not recruiting NCT02077868 - Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment Phase 3
Completed NCT02414009 - Study to Compare CAPTEM vs FOLFIRI as Second Line Treatment in Advanced, Colorectal Cancer Patients Phase 2
Active, not recruiting NCT01949194 - Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers Phase 2
Withdrawn NCT01915472 - A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer Phase 2