Oxaliplatin, Irinotecan, and Capecitabine in Treating Patients With Advanced or Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

NCT00217711 | Completed Phase 1 DMC

• 2 other identifiers: SAKK 41/03EU-20524
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, 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 capecitabine when given together with oxaliplatin and irinotecan and to see how well they work in treating patients with advanced or metastatic colorectal cancer that cannot be removed by surgery.

Conditions

Colorectal Cancer

Keywords

stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (2)

• capecitabine + oxaliplatin + irinotecan dose finding

  Determine the maximum tolerated dose and recommended phase II dose of capecitabine administered in combination with oxaliplatin and irinotecan in patients with unresectable advanced or metastatic colorectal cancer. (Phase I)

  30 days

• Efficacy of Oxaliplatin, Irinotecan, and Capecitabine

  Determine the efficacy of this regimen in these patients (Phase II)

  2 months

Secondary Outcomes (5)

• Objective response (CR or PR) as measured after completion of study treatment

  2 months

• Adverse events as measured after completion of study treatment

  2 months

• Time to progression

  life-long

• Time to treatment failure as measured after completion of study treatment

  life-long

• Overall survival

  life-long

Study Arms (1)

Arm A

ACTIVE COMPARATOR

Oxaliplatin, Irinotecan, and Capecitabine

Drug: Capecitabine; Drug: irinotecan hydrochloride; Drug: oxaliplatin

Interventions

Capecitabine DRUG

capecitabine

Arm A

irinotecan hydrochloride DRUG

irinotecan hydrochloride

Arm A

oxaliplatin DRUG

oxaliplatin

Arm A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed unresectable advanced or metastatic colorectal cancer * Measurable disease (phase II only) * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI * No presence or history of CNS metastases PATIENT CHARACTERISTICS: Age * 18 to 70 Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.25 times upper limit of normal (ULN) (1.5 times ULN if liver metastases are present) * AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present) Renal * Creatinine clearance \> 60 mL/min Cardiovascular * No New York Heart Association class III-IV congestive heart failure * No symptomatic coronary artery disease * No uncontrolled cardiac arrhythmia * No myocardial infarction within the past year * No other clinically significant cardiac disease Immunologic * No active autoimmune disease * No uncontrolled infection * No prior severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil * No known hypersensitivity to any component of study drugs Other * Not pregnant or nursing * Negative pregnancy test * Patients must use effective contraception during and for 1 year after study participation * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer * No peripheral neuropathy \> grade 1 of any origin (e.g., alcohol or diabetes) * No nausea, vomiting, or malabsorption syndrome that would preclude ingestion or absorption of oral medication * No psychiatric disability that would preclude study compliance * No uncontrolled diabetes * No other serious underlying medical condition that would preclude study participation * No known dihydropyrimidine dehydrogenase deficiency PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent prophylactic hematopoietic growth factors Chemotherapy * More than 6 months since prior adjuvant fluoropyrimidine chemotherapy * No other prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No concurrent radiotherapy * Concurrent radiotherapy of a single painful lesion allowed Surgery * Not specified Other * More than 30 days since prior clinical trial participation * No other concurrent experimental drugs * No other concurrent anticancer therapy * No concurrent sorivudine or its chemically-related analogues (e.g., lamivudine)

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

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (4)

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Hirslanden Klinik Aarau

Lausanne, CH-1011, Switzerland

Location

City Hospital Triemli

Zurich, CH-8063, Switzerland

Location

Related Publications (1)

• von Moos R, Roth A, Ruhstaller T, Widmer L, Uhlmann C, Cathomas R, Koberle D, Simcock M, Lanz D, Popescu R. Oxaliplatin, irinotecan and capecitabine (OCX) for first-line treatment of advanced/metastatic colorectal cancer: a phase I trial (SAKK 41/03). Onkologie. 2010;33(6):295-9. doi: 10.1159/000313598. Epub 2010 May 14.

  PMID: 20523092 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Irinotecan; 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; Camptothecin; Alkaloids; Coordination Complexes; Organic Chemicals

Study Officials

• Razvan Popescu, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: May 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: October 1, 2011
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

CH (4)