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Home > "L" Clinical Trials Conditions > Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors  Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
For Condition: Lung Cancer,ovarian sarcoma,Head and Neck Cancer,Oropharyngeal Cancer,lip and oral cavity cancer,ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: 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.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of lurtotecan liposome with 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. PROTOCOL 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. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 (i.e., no evidence of increasing disease by CT scan for at least 4 weeks); CNS metastases allowed - 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 -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 or mitomycin and 4 weeks for carboplatin) and recovered; At least 1 year since prior high-dose chemotherapy with marrow or stem cell support; Prior cisplatin-containing regimen allowed, if total cisplatin dose no greater 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 to no more than 25% of bone marrow reserve, except for low-dose nonmyelosuppression, and recovered - 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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CarolynBritten, Study Chair, National Cancer Institute of Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Additional Information:
Study ID Numbers: CDR0000068051; NEXSTAR-110-05,CAN-NCIC-IND133
Study Start Date: April 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006036
Other Lung Cancer Studies:
1. Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
2. Gene Therapy in Preventing Cancer in Patients With Premalignant Carcinoma of the Oral Cavity or Pharynx
3. Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer
4. SU5416 in Treating Patients With Advanced or Recurrent Cancer of the Head and Neck
5. Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer
Related Studies:
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Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
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