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Colorectal CancerPhase 1NCT00081237

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

A Phase 1 study testing OSI-7904L and oxaliplatin in people with Colorectal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
OSI-7904L and oxaliplatin
How many people
15 participants
Where
2 sitesin 2 countries
Study dates
Feb 2004to Aug 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site

  • Medizinische Hochschule Hannover

    Hanover, D-30625

Other trials in Germany

United Kingdom1 site

  • Christie Hospital N.H.S. Trust

    Manchester, England, M20 4BX

Other trials in United Kingdom

About this study

Official title: A Phase I Study of OSI-7904L In Combination With Oxaliplatin In Patients With Advanced Colo-Rectal Cancer

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.

Read the detailed description

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.

Being tested
OSI-7904L, oxaliplatin
Keywords
recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose and recommended dose for future trials as measured by CTC v3.0

Secondary outcomes (4)

  1. Safety profile as measured by CTC v3.0

  2. Response as measured by RECIST every 6 weeks (2 courses)

  3. Pharmacodynamics as measured by drug concentration in the blood during course 1

  4. Time to progression as measured by Kaplan Meier and RECIST every 6 weeks during treatment and then every 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2004 (estimated)
  2. Study startFeb 2004
  3. Primary completionAug 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00081237
Sponsor's protocol ID
EORTC-16033
Other IDs
EORTC-16033, OSI-EORTC-16033
Status last verified
Jun 2013
First submitted
7 Apr 2004
Last updated
12 Jun 2013
Results posted
No

Publications

  • Clamp AR, Schoffski P, Valle JW, Wilson RH, Marreaud S, Govaerts AS, Debois M, Lacombe D, Twelves C, Chick J, Jayson GC; EORTC New Drug Development Group. A phase I and pharmacokinetic study of OSI-7904L, a liposomal thymidylate synthase inhibitor in combination with oxaliplatin in patients with advanced colorectal cancer. Cancer Chemother Pharmacol. 2008 Apr;61(4):579-85. doi: 10.1007/s00280-007-0509-5. Epub 2007 May 23.

    PubMed 17520255

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OSI-7904L and oxaliplatin in people with Colorectal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose and recommended dose for future trials as measured by CTC v3.0. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00081237, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.

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