Lurtotecan Liposome in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00003891
First received: June 2, 2000
Last updated: November 7, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: lurtotecan liposome
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of NX211 Given as an IV Infusion Days 1, 2 and 3 Every 3 Weeks in Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Estimated Enrollment: 25
Study Start Date: February 1999
Study Completion Date: September 2009
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and the future dose of lurtotecan liposome in patients with advanced solid tumors. II. Assess the toxicity and pharmacokinetics of this treatment regimen in this patient population. III. Assess the response to this regimen by patients with measurable disease.

OUTLINE: This is a dose escalation, multicenter study. Patients receive lurtotecan liposome (NX211) IV over 30 minutes on days 1, 2, and 3. Courses are repeated every 3 weeks. Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease progression. The dose of NX211 is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed at 4 weeks and every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-15 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003891

Locations
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Karen A. Gelmon, MD British Columbia Cancer Agency
  More Information

Additional Information:
Publications:
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.
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.

ClinicalTrials.gov Identifier: NCT00003891     History of Changes
Other Study ID Numbers: I123, CAN-NCIC-IND123, NEXSTAR-110-02, CDR0000067060
Study First Received: June 2, 2000
Last Updated: November 7, 2010
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Lurtotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014