Lurtotecan Liposome in Treating Patients With Advanced Solid Tumors

NCT00003891 | Completed Phase 1 DMC

• 4 other identifiers: I123CAN-NCIC-IND123NEXSTAR-110-02CDR0000067060
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of lurtotecan liposome in treating patients who have advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

lurtotecan liposome DRUG

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 confirmed advanced solid tumors that are unresponsive to existing therapy and for which no curative therapy exists Evidence of disease other than tumor marker elevation No untreated CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST and ALT no greater than 2.5 times ULN (no greater than 5 times ULN for liver metastases) Renal: Creatinine no greater than upper limit of normal Cardiovascular: Not specified Pulmonary: Not specified Other: No prior malignancy within past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception No active or uncontrolled infection No other serious illness or medical condition No known hypersensitivity to systemic liposomal formulation or any drug chemically related to study drug PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No greater than 3 prior chemotherapy regimens (adjuvant and metastatic) At least 3 weeks since prior adjuvant and metastatic chemotherapy (6 weeks for nitrosoureas or mitomycin and 4 weeks for carboplatin or other experimental anti cancer drugs) and recovered At least 1 year since prior high dose chemotherapy with bone marrow or stem cell support No other concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: No prior radiotherapy to greater than 25% of bone marrow At least 4 weeks since prior radiotherapy, except for low dose myelosupressive radiotherapy, and recovered Concurrent palliative radiotherapy allowed Surgery: Not specified Other: At least 4 weeks since prior experimental drug or anticancer therapy No other concurrent investigational or anticancer therapy

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

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• Nexstar Pharmaceuticals: collaborator

Study Sites (2)

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Related Publications (3)

• Goetz AD, Hammond LA, Hao D, et al.: A phase I and pharmacokinetic (PK) study of NX211 (liposomal lurtotecan) administered weekly x 4 every 6 weeks in patients with advanced solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-388, 2002.

  BACKGROUND

• Hamilton M, Wolf J, Demetri GD, et al.: Phase I pharmacokinetics of NX211 (liposomal lurtotecan) in patients with solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-357, 2002.

  BACKGROUND

• Gelmon K, Hirte H, Fisher B, Walsh W, Ptaszynski M, Hamilton M, Onetto N, Eisenhauer E. A phase 1 study of OSI-211 given as an intravenous infusion days 1, 2, and 3 every three weeks in patients with solid cancers. Invest New Drugs. 2004 Aug;22(3):263-75. doi: 10.1023/B:DRUG.0000026252.86842.e2.

  PMID: 15122073 RESULT

Study Officials

• Karen A. Gelmon, MD

  British Columbia Cancer Agency

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: June 17, 2004
• Study Start: February 25, 1999
• Primary Completion: June 8, 2001
• Study Completion: September 22, 2008
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)