Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: SN-38 liposome

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00311610

CALGB-80402

U10CA031946 (U.S. NIH Grant/Contract)

CDR0000467234 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

SN-38 liposome

Experimental group

Description:

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.

Treatment:

Drug: SN-38 liposome