Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer

NCT00311610 | Completed Phase 2

• 3 other identifiers: CALGB-80402U10CA031946CDR0000467234
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

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.

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  q 2 cycles during tx

Secondary Outcomes (3)

• Toxicity

  q cycle during tx

• Progression-free survival

  3 years

• Overall survival

  3 years

Study Arms (1)

SN-38 liposome

EXPERIMENTAL

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.

Drug: SN-38 liposome

Interventions

SN-38 liposome DRUG

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

SN-38 liposome

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, 92120, United States

Location

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Union Hospital Cancer Program at Union Hospital

Elkton MD, Maryland, 21921, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

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

Chapel Hill, North Carolina, 27599-7295, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, United States

Location

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

Columbus, Ohio, 43210-1240, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Allyson Ocean, MD

  Weill Medical College of Cornell University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2006
• First Posted: April 6, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: June 1, 2010
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

US (10)