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Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00311610
Enrollment
30
Registered
2006-04-06
Start date
2006-01-31
Completion date
2010-06-30
Last updated
2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer

Brief 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.

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.

Interventions

DRUGSN-38 liposome

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Objective response rateq 2 cycles during tx

Secondary

MeasureTime frame
Toxicityq cycle during tx
Progression-free survival3 years
Overall survival3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026