Gemcitabine, Capecitabine, and Oxaliplatin as Second-Line Therapy in Treating Patients With Advanced Colorectal Cancer Previously Treated With Irinotecan

NCT00496704 | Unknown Phase 1

• 2 other identifiers: CDR0000549901YONSEI-YCC-4-20060231
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with capecitabine and oxaliplatin as second-line therapy and to see how well it works in treating patients with advanced colorectal cancer previously treated with irinotecan.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colon; recurrent colon cancer; stage III colon cancer; stage IV colon cancer; adenocarcinoma of the rectum; recurrent rectal cancer; stage III rectal cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate as assessed by RECIST criteria

Secondary Outcomes (5)

• Progression-free survival

• Duration of response

• Time to treatment failure

• Overall survival

• Time to response

Interventions

capecitabine DRUG

gemcitabine hydrochloride DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed advanced colorectal adenocarcinoma * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * Must have received prior irinotecan hydrochloride with a progression-free interval of \< 3 months * No symptomatic brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Total bilirubin ≤ 2 times upper limit of normal (ULN) * AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present) * Creatinine ≤ 1.5 times ULN * No significant cardiac abnormalities by ECG * No known hypersensitivity to the study drugs or any of their components * No myocardial infarction within the past 12 months * No uncontrolled congestive heart failure * No cardiovascular disorder ≥ grade 3 despite treatment * No other malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix * No significant disease, that in the opinion of the investigator, would preclude study treatment (e.g., active infections, interstitial lung disease, or peripheral neuropathy) * No history of significant neurological or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder) * No legal incapacity or limited legal capacity that would preclude study participation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior therapy * More than 30 days since prior participation in another clinical trial * No concurrent warfarin, phenprocoumon, phenytoin, or sorivudine

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Joong B. Ahn, MD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: January 1, 2007
• Primary Completion: August 1, 2009
• Last Updated: August 21, 2009

Record last verified: 2009-08

Locations

KR (1)