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Adenocarcinoma of the ColonPhase 1/2NCT00005818

SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer

A Phase 1/2 study testing irinotecan hydrochloride, semaxanib and laboratory biomarker analysis in people with Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by National Cancer Institute (NCI) at 1 site in United States.

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

Phase I/II trial to study the effectiveness of combining SU5416 and irinotecan in treating patients who have advanced colorectal cancer. SU5416 may stop the growth of colorectal cancer by stopping blood flow to the tumor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
irinotecan hydrochloride, semaxanib and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteUnited States
Study dates
Mar 2000to Mar 2003
Phase
Phase 1/2
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

Who may be able to join

  • Patients must have histologically confirmed adenocarcinoma of the colon or rectum
  • Patients must have locally advanced or metastatic disease not amendable to potentially curative treatment
  • Patients must have an ECOG performance status of 0-2
  • Men and women of any racial and ethnic group
  • Absolute neutrophil count (neutrophils + bands) of >= 1,500/ul
  • Platelet count of >= 100,000/ul
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  • Patients must have a serum creatinine of =< 1.5 mg/dL or a calculated creatinine clearance >= 60 mL/min
  • Serum bilirubin =< 1.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor
  • SGOT must be =< 3 times institutional upper limit of normal
  • Patients must be fully recovered from any previous surgery (at least 4 weeks from major surgery)
  • Patients must have recovered from prior radiation therapy (at least 4 weeks from radiation)
  • Fertile patients (male and female) must agree to use a medically effective contraceptive method throughout the treatment period and for 3 months following cessation of treatment
  • Patients must provide written informed consent
  • Patients must have either measurable or evaluable disease; measurable disease is defined as at least one bidimensionally measurable lesion >= 1 x 1 cm that is outside the field of any prior radiation therapy
  • In Phase I: Patients with a history of a prior malignancy are eligible for treatment
  • In Phase II: Patients who have undergone potentially curative therapy for a prior malignancy and who have had no evidence of that disease for > 5 years are eligible for treatment; adequately treated basal cell or squamous cell skin cancer does not apply
  • In the Phase I portion of the study the following eligibility criteria must be met:
  • Patients must have received no more than two prior chemotherapy regimens (one of which must have contained a fluorinated pyrimidine) for locally advanced or metastatic disease; if a patient progressed while on or within 6 months of adjuvant therapy, the adjuvant regimen will be considered as treatment for metastatic disease
  • In the Phase II portion of the study the following eligibility criteria must be met:
  • Patients must have received one and only one prior chemotherapy regimen, which must have contained a fluorinated pyrimidine, for treatment of locally advanced or metastatic disease; if a patient progressed while on or within 6 months of adjuvant therapy, the adjuvant regimen will be considered as treatment for metastatic disease

Who cannot join

  • Patients who have previously received SU5416, CPT-11, or any topoisomerase I inhibitor
  • Patients with uncompensated coronary artery disease on electrocardiogram or physical examination, or with a history of myocardial infarction, or severe/unstable angina in the past 6 months are not eligible
  • Patients with diabetes mellitus with severe peripheral vascular disease and patients who have had a deep venous or arterial thrombosis (including pulmonary embolism) within 3 months of entry are not eligible
  • Patients with known allergy to Cremaphor, or Cremophor-based drug products
  • Patients with any active or uncontrolled infection
  • Patients with psychiatric disorders that would interfere with consent or follow-up
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  • CPT-11 is known to have teratogenic potential and may be excreted in milk; the current SU5416 Investigator's Brocure indicates that teratogenicity studies have not yet been performed; however, other antiangiogenesis drugs, such as thalidomide, are known to have teratogenic potential; based on the available data, there is potential for significant risk to a developing fetus or breast-feeding child; therefore, pregnant women, women who are breast-feeding, and fertile men and women, unless utilizing birth control are excluded from this study; a negative pregnancy test must be documented during the screening period for women of childbearing potential
  • Patients with either a prior history of or clinically apparent central nervous system metastases or leptomeningeal carcinomatosis disease
  • Patients with a history of seizures or who are receiving phenytoin, phenobarbital, or other antipileptic prophylaxis
  • Patients with uncontrolled diabetes mellitus
  • Patients with known Gilbert's Disease (may have excessive CPT-11-induced toxicity)
  • Patients with any other severe concurrent disease which in the judgement of the investigator would make the patient inappropriate for the study
  • Patients who have received any investigational drug =< 30 days prior to enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase I/II Study of Escalating Doses of SU5416 (NSC 696819) in Combination With CPT-11 in Patients With Advanced Colorectal Carcinoma

Phase I/II trial to study the effectiveness of combining SU5416 and irinotecan in treating patients who have advanced colorectal cancer. SU5416 may stop the growth of colorectal cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Read the detailed description

OBJECTIVES:

  1. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity of SU5416 in combination with irinotecan in patients with advanced colorectal cancer.

II. Determine time to disease progression, objective response rate, and survival time in these patients receiving this regimen at the MTD.

III. Evaluate the safety and tolerance of this regimen in these patients.

OUTLINE: This is a dose-escalation study of SU5416.

Patients receive irinotecan IV over 90 minutes on day 1 of weeks 1-4 and SU5416 IV over 60 minutes on days 1 and 4 of weeks 1-6. Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of SU5416 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. Once the MTD is determined, additional patients are accrued to receive treatment with SU5416 and irinotecan at the recommended phase II dose.

Patients are followed every 3 months.

Being tested
irinotecan hydrochloride, semaxanib, laboratory biomarker analysis
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

  • irinotecan hydrochlorideDrug

    Also called Campto, Camptosar, CPT-11, irinotecan

    Given IV

  • semaxanibDrug

    Also called semoxind, SU5416, Sugen 5416

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00005818
Study groupRoleWhat they receive
Treatment (irinotecan hydrochloride, semaxanib)ExperimentalPatients receive irinotecan IV over 90 minutes on day 1 of weeks 1-4 and SU5416 IV over 60 minutes on days 1 and 4 of weeks 1-6. Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression.
Receives: Drug: irinotecan hydrochloride; Drug: semaxanib; Other: laboratory biomarker analysis

What is being measured

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

  1. Time to disease progression (TTP)

    Estimated using the Kaplan-Meier method. Associated 95% confidence intervals will be computed.

    Measured: 6 months

Secondary outcomes (3)

  1. Overall tumor response rate (CR + PR)

    Associated 95% confidence intervals.

    Measured: Up to 3 years

  2. Overall survival

    Estimated using the Kaplan-Meier method.

    Measured: From date of entry on study to the date of death of the patients; assessed up to 3 years

  3. Toxicity graded using the NCI CTC version 2.0

    Measured: Up to 3 years

Timeline

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

  1. First posted5 May 2003 (estimated)
  2. Study startMar 2000
  3. Primary completionMar 2003

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005818
Sponsor's protocol ID
NCI-2012-02330
Other IDs
ID-99-243, N01CM17003, CDR0000067823
Status last verified
Jan 2013
First submitted
2 Jun 2000
Last updated
23 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing irinotecan hydrochloride, semaxanib and laboratory biomarker analysis in people with Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by National Cancer Institute (NCI) at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 20 inclusion and 13 exclusion criteria. 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Time to disease progression (TTP) (time frame: 6 months). 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 NCT00005818.

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 23 Jan 2013.

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