Suspended

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

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What is being tested

capecitabine

+ gefitinib
+ oxaliplatin
Drug
Who is being recruted

Colorectal Cancer

From 18 to 80 Years
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 2004

Summary

Principal SponsorRoswell Park Cancer Institute
Last updated: February 1, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

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. OBJECTIVES: Primary * Determine the maximum tolerated dose of capecitabine when given in combination with oxaliplatin and gefitinib in patients with metastatic colorectal cancer. (phase I) * Determine the response rate in patients treated with this regimen. (phase II) Secondary * Determine the safety and toxic effects of this regimen in these patients. * Determine the 1-year survival of patients treated with this regimen. (phase II) * Determine the progression-free and overall survival of patients treated with this regimen. (phase II) OUTLINE: This is an open-label, nonrandomized, phase I, dose-escalation study of capecitabine followed by a phase II study. * Phase I: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive oral gefitinib once daily beginning 5 days before the initiation of capecitabine and oxaliplatin and continuing for the duration of study treatment. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * Phase II: Patients receive oral capecitabine (at the MTD determined in phase I), oxaliplatin IV, and oral gefitinib as in phase I. Patients are followed for survival. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of this study within 1-12 months; and a total of 26 patients will be accrued for the phase II portion of this study within 8-13 months.

Official TitleA Phase I/II Study of Capecitabine (XELODA®, Roche) Plus Oxaliplatin (Eloxatin®, Sanofi) Plus ZD 1893 (IRESSA®) in the Treatment of Metastatic Colorectal Cancer 
Principal SponsorRoswell Park Cancer Institute
Last updated: February 1, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
10 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 80 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colorectal Cancer
Criteria

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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Roswell Park Cancer InstituteBuffalo, United StatesSee the location

SuspendedOne Study Center