Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
|First Received Date ICMJE||July 5, 2000|
|Last Updated Date||November 7, 2010|
|Start Date ICMJE||April 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00006036 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors|
|Official Title ICMJE||A Phase I Study of NX 211 in Combination With Cisplatin Given as an IV Infusion Days 1, 2, and 3 Every 3 Weeks in Patients With Solid Tumors|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of liposomal lurtotecan plus cisplatin in treating patients who have advanced or metastatic solid tumors.
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of lurtotecan liposome and cisplatin in patients with advanced solid tumors. II. Determine the toxicity profile, dose-limiting toxic effects, and the pharmacokinetics of this treatment regimen in this patient population. III. Determine any correlation between toxicity profile and pharmacokinetics of this treatment regimen in these patients. IV. Determine the objective tumor response to this treatment regimen in patients with measurable disease (previously untreated solid tumors) entered at the recommended phase II dose.
OUTLINE: This is an open-label, multicenter, dose-escalation study of lurtotecan liposome. Patients receive cisplatin IV over 1 hour followed by lurtotecan liposome IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Once the total dose of cisplatin is reached, patients receive lurtotecan liposome alone. Patients achieving complete response (CR) continue therapy for 2 courses after documentation of confirmed CR. Patients achieving partial response (PR) continue therapy until progression or for 2 courses after documentation of stable PR. Patients with stable disease continue therapy for a maximum of 6 courses. Cohorts of 3-6 patients receive escalating doses of lurtotecan liposome until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 10 patients with previously untreated solid tumors are treated at the recommended phase II dose (1 dose below the MTD). Patients are followed at 4 weeks and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-15 months.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Study Arm (s)||Not Provided|
|Publications *||MacKenzie MJ, Hirte HW, Siu LL, Gelmon K, Ptaszynski M, Fisher B, Eisenhauer E. A phase I study of OSI-211 and cisplatin as intravenous infusions given on days 1, 2 and 3 every 3 weeks in patients with solid cancers. Ann Oncol. 2004 Apr;15(4):665-70.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||December 2009|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced and/or metastatic solid tumor refractory to standard curative therapy or for which no curative therapy exists Clinically or radiographically documented disease No tumor marker elevation as only evidence of disease No untreated brain or meningeal metastases Previously treated and stable CNS metastases allowed (i.e., no evidence of increasing disease by CT scan for at least 4 weeks) Recommended phase II dose portion of study: Previously untreated advanced and/or metastatic disease for which a cisplatin-based regimen is indicated (e.g., non-small cell lung cancer, small cell lung cancer, ovarian, or head and neck cancer) At least one measurable lesion at least 20 mm by physical exam or x-ray or at least 10 mm by spiral CT scan
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute 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/ALT no greater than 2.5 times ULN (5 times ULN if documented liver metastases) Renal: Creatinine no greater than ULN OR Creatinine clearance at least 60 mL/min Other: No greater than grade 1 neuropathy or ototoxicity No other prior or concurrent malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or cervical cancer (for recommended phase II dose) No active or uncontrolled infections No other serious illnesses or medical conditions that would preclude study No known hypersensitivity to systemic liposomal formulation or any drug chemically related to study drug Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy Recovered from prior immunotherapy Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen (adjuvant and/or metastatic) except for nonmyelosuppressive agents (e.g., signal transduction inhibitors or immunotherapy) At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin and 4 weeks for carboplatin) and recovered At least 1 year since prior high-dose chemotherapy with marrow or stem cell support No prior total cisplatin dose of more than 300 mg/m2 No prior chemotherapy (for recommended phase II dose) Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 25% of bone marrow reserve, except for low-dose nonmyelosuppression Surgery: Not specified Other: At least 4 weeks since other prior experimental drugs or anticancer therapy and recovered No other concurrent investigational or anticancer therapy
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Canada|
|NCT Number ICMJE||NCT00006036|
|Other Study ID Numbers ICMJE||I133, CAN-NCIC-IND133, NEXSTAR-110-05, CDR0000068051|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||NCIC Clinical Trials Group|
|Collaborators ICMJE||Not Provided|
|Information Provided By||NCIC Clinical Trials Group|
|Verification Date||March 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP