Completed

OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer

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What is being tested

OSI-7904L

+ oxaliplatin
Drug
Who is being recruted

Colorectal Cancer

Over 18 Years
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2004

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: June 12, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2004Actual date on which the first participant was enrolled.

RATIONALE: OSI-7904L may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining OSI-7904L with oxaliplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of OSI-7904L and oxaliplatin in treating patients with refractory or recurrent advanced colorectal cancer. OBJECTIVES: Primary * Determine the dose-limiting toxicity of OSI-7904L and oxaliplatin in patients with refractory or recurrent advanced colorectal cancer. * Determine the maximum tolerated dose of this regimen in these patients. * Determine a safe dose for this regimen in these patients. Secondary * Determine the pharmacokinetic profile of this regimen in these patients. * Determine the safety profile of this regimen in these patients. * Determine the antitumor activity of this regimen in these patients. OUTLINE: This is a nonrandomized, multicenter, open-label, dose-escalation study. Patients receive oxaliplatin IV over 2 hours followed by OSI-7904L IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of OSI-7904L and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. A maximum of 12 patients receive treatment at the MTD. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.

Official TitleA Phase I Study of OSI-7904L In Combination With Oxaliplatin In Patients With Advanced Colo-Rectal Cancer 
Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: June 12, 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
15 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.
Over 18 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 confirmed colorectal cancer * Radiologic evidence of advanced disease * At least 1 measurable lesion at least 20 mm OR at least 10 mm by spiral CT scan * Indicator lesions in a previously irradiated field are allowed provided the irradiated lesion has clearly progressed OR a new lesion has developed in the irradiated field * Failed 1, and only 1, line of prior chemotherapy for advanced/metastatic disease * Disease progression during chemotherapy OR within 6 months after completion of treatment * No symptomatic brain metastases meeting any of the following criteria: * Unstable * Inadequately controlled with fixed-dose oral steroids * Potentially life-threatening * Required radiotherapy with the past 28 days PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * AST and ALT \< 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Bilirubin \< 1.5 times ULN * No hepatitis * No cirrhosis Renal * Creatinine \< 1.5 times ULN Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * HIV negative * No preexisting neuropathy ≥ grade 2 * No active or uncontrolled infection * No other serious illness or medical condition * No chronic alcohol abuse * No known hypersensitivity to systemic liposomal formulations or compounds chemically related to OSI-7904L or oxaliplatin * No prior psychiatric or neurologic condition that would preclude study compliance or giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * At least 21 days since prior immunotherapy * At least 21 days since prior monoclonal antibody therapy Chemotherapy * See Disease Characteristics * At least 21 days since prior chemotherapy and recovered\* * No prior oxaliplatin NOTE: \*Alopecia allowed Endocrine therapy * See Disease Characteristics * At least 21 days since prior hormonal therapy Radiotherapy * See Disease Characteristics * At least 21 days since prior radiotherapy and recovered * No prior radiotherapy to more than 25% of bone marrow reserve Surgery * Recovered from prior surgery Other * At least 21 days since prior tyrosine kinase inhibitor therapy * More than 21 days since prior investigational agents * No other concurrent anticancer therapy * No other concurrent investigational agents


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 2 locations
Suspended
Medizinische Hochschule HannoverHannover, GermanySee the location
Suspended
Christie Hospital N.H.S. TrustManchester, United Kingdom

Completed2 Study Centers