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NCT Number: NCT01322152

Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer

The objectives of this study are to evaluate the efficacy and tolerability of single-week regimen of irinotecan plus capecitabine in the first-line or second-line treatment of advanced colorectal cancer.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

About this study

Irinotecan and capecitabine are approved to be the effective drugs for the advanced colorectal cancer patients. However, the combination of these two drugs are not regularly recommended due to the severe diarrhea as the most common adverse event.This study was designed to explore whether the single-week regimen of irinotecan plus capecitabine improves efficacy and does not increase the toxicity in advanced colorectal cancer patients in China.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Histologically confirmed colorectal cancer
  • Age 18-70 years old
  • Advanced colorectal cancer patients, first-line or second-line treatment, the adjuvant treatment including the oxaliplatin or/and 5FU should be finished six months before
  • Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • ECOG 0-1
  • Life expectancy of more than 3 months.
  • Normal laboratory values: hemoglobin > 90g/dl, neutrophils > 1.5×10^9/L, platelets > 100×10^9/L, serum creatinine < 1.5×upper limit of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN, AKP < 4×ULN

Exclusion criteria

  • Pregnant or lactating patients
  • Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
  • Active or uncontrolled infection
  • Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
  • Patients could not swallow the tablets
  • Concomitant with brain metastases

Treatment and study plan

irinotecan, capecitabine

Drug

Irinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days.

Primary outcomes

  1. Rate of Diarrhea

    Time frame: eight weeks

Secondary outcomes

  1. Progression free survival

    Time frame: eight weeks

  2. Response rate

    Time frame: eight weeks

  3. Disease control rate

    Time frame: eight weeks

  4. Overall survival

    Time frame: eight weeks

  5. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: eight weeks

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 24, 2011
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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