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Colorectal CancerPhase 2NCT00311610

Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer

A Phase 2 study testing SN-38 liposome in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 10 sites 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

RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients with metastatic colorectal cancer. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Colorectal Cancer
What is being tested?
SN-38 liposome
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
10 sitesUnited States
Study dates
Jan 2006to Jun 2010
Phase
Phase 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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically determined metastatic colorectal cancer*
  • Primary lesion confirmed endoscopically, surgically, or radiologically NOTE: * Patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease, unless more than 5 years between primary surgery and development of metastatic disease OR primary cancer was stage I
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Nonmeasurable lesions include the following:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Abdominal masses not confirmed and followed by imaging techniques
  • Cystic lesions
  • UGT1A1*1 homozygous or UGT1A1*28 heterozygous genotype status
  • Patients with homozygous UGT1A1*28 genotype not eligible
  • Received at least 1 prior regimen with oxaliplatin for metastatic disease
  • Recurrent disease following prior adjuvant therapy allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine normal
  • Bilirubin normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception duration and for 3 months after completion of study treatment
  • No known Gilbert's disease or other chronic liver disease
  • No colonic or small bowel disorders (e.g., inflammatory bowel disease, Crohn's disease, or ulcerative colitis) that predispose the patients to uncontrolled diarrhea (i.e., > 3 watery or soft stools daily at baseline in patients without a colostomy or ileostomy)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • No prior irinotecan
  • Prior pelvic radiotherapy allowed as long as measurable lesion is outside irradiated field
  • No concurrent palliative radiotherapy
  • No other concurrent chemotherapy
  • No concurrent steroids except those given for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic or for prevention of infusion reaction

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • Union Hospital Cancer Program at Union Hospital

    Elkton MD, Maryland, 21921

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Kaiser Permanente Medical Office -Vandever Medical Office

    San Diego, California, 92120

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

Other trials in United States

About this study

Official title: Phase II Trial of LE SN38 in Patients With Metastatic Colorectal Cancer After Progression on Oxaliplatin

RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients with metastatic colorectal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the objective response rate following treatment with SN-38 liposome as a second-line treatment in patients with metastatic colorectal cancer.

Secondary

  • Determine the toxicity profile of this drug in these patients.
  • Determine the proportion of patients treated with this drug who experience any grade 3 or greater toxicity.
  • Determine progression-free survival and overall survival for patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for up to 3 years.

Being tested
SN-38 liposome
Keywords
recurrent colon cancer, stage IV colon cancer, recurrent 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.

  • SN-38 liposomeDrug

    38 mg/sq m IV infusion over 30 min q 21 days (1 cycle) until progression

Study groups in NCT00311610
Study groupRoleWhat they receive
SN-38 liposomeExperimentalPatients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for up to 3 years.
Receives: Drug: SN-38 liposome

What is being measured

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

  1. Objective response rate

    Measured: q 2 cycles during tx

Secondary outcomes (3)

  1. Toxicity

    Measured: q cycle during tx

  2. Progression-free survival

    Measured: 3 years

  3. Overall survival

    Measured: 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 posted6 Apr 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionJan 2007
  4. Study completionJun 2010

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00311610
Sponsor's protocol ID
CALGB-80402
Other IDs
U10CA031946, CALGB-80402, CDR0000467234
Status last verified
Jun 2016
First submitted
5 Apr 2006
Last updated
29 Jun 2016
Results posted
No
Data monitoring committee
No

Publications

  • Ocean AJ, Niedzwiecki D, Atkins JN, et al.: LE-SN38 for metastatic colorectal cancer after progression on oxaliplatin: results of CALGB 80402. [Abstract] J Clin Oncol 26 (Suppl 15): A-4109, 2008.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SN-38 liposome in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 10 sites 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?

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 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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 phase mean?

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?

Objective response rate (time frame: q 2 cycles during tx). 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 NCT00311610, 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 29 Jun 2016.

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