Capecitabine, Oxaliplatin, and Gefitinib in Treating Patients With Metastatic Colorectal Cancer

NCT00087334 | Terminated Phase 1

• 3 other identifiers: I 17403RPCI-I-17403ZENECA-IRUSIRES0414
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining capecitabine and oxaliplatin with gefitinib 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 gefitinib and to see how well they work in treating patients with metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

• Response rate

Secondary Outcomes (4)

• Toxicity

• 1-year survival (phase II)

• Progression-free survival (phase II)

• Overall survival in (phase II)

Interventions

capecitabine DRUG

gefitinib DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed\* colorectal cancer * Metastatic disease * The site of the primary tumor must have been confirmed endoscopically, radiologically, or surgically to be the colon or rectum NOTE: \*Confirmation is not required for recurrent metastatic disease unless an interval of \> 5 years has elapsed between the initial primary surgery and the development of metastases * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * No CNS metastases PATIENT CHARACTERISTICS: Age * 18 to 80 Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL (transfusion allowed) Hepatic * AST and ALT ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ ULN * No unstable or uncompensated hepatic disease Renal * Creatinine \< 1.5 times ULN OR * Creatinine clearance \> 60 mL/min * No unstable or uncompensated renal disease Cardiovascular * No unstable or uncompensated cardiac disease Pulmonary * No evidence of clinically active interstitial lung disease * Asymptomatic patients with chronic stable radiographic changes are eligible * No unstable or uncompensated respiratory disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No known hypersensitivity to gefitinib or any of its excipients * No known hypersensitivity to platinum compounds, fluorouracil, or capecitabine * No severe or uncontrolled systemic disease * Able to receive oral medication * No known dihydropyrimidine dehydrogenase (DPD) deficiency * No known peripheral neuropathy ≥ grade 1 * Absence of deep tendon reflexes as the sole neurological abnormality allowed * No other significant clinical disorder or laboratory finding that would preclude study participation * No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix (phase II only) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 4 weeks since prior chemotherapy for metastatic colorectal cancer (phase I) * No prior chemotherapy for metastatic disease (phase II) * Prior fluorouracil and leucovorin calcium in the adjuvant setting allowed provided the last treatment was administered more than 6 months before the development of metastatic disease * No prior irinotecan and oxaliplatin (phase II) Endocrine therapy * Not specified Radiotherapy * No concurrent radiotherapy for colorectal cancer Surgery * See Disease Characteristics * More than 4 weeks since prior major surgery (e.g., laparotomy) Other * Recovered from all prior therapy (no unresolved chronic toxicity \> grade 2) * More than 4 weeks since prior investigational drugs * No prior epidermal growth factor receptor inhibitor therapy (phase II) * No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's wort) * No other concurrent investigational drugs * No other concurrent systemic therapy for colorectal cancer

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Gefitinib; 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; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Marwan Fakih, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: January 1, 2004
• Primary Completion: November 1, 2005
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

US (1)