Clinical trial · Interventional
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
NCT00311610CI-TRIAL-00022767completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SN-38 liposome | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SN-38 liposome
- 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.
- interventionNames
- Drug: SN-38 liposome
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- q 2 cycles during tx
Secondary outcomes (3)
- measure
- Toxicity
- timeFrame
- q cycle during tx
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 reactionReferences
Publications (1)
- RESULTOcean 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.