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Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors

This study is ongoing, but not recruiting participants.

Sponsored by: National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006036
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Lung Cancer
Ovarian Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: cisplatin
Drug: lurtotecan liposome
Phase I

MedlinePlus related topics:   Cancer    Head and Neck Cancer    Lung Cancer    Ovarian Cancer   

Drug Information available for:   Cisplatin    Gi 147211    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   April 2000

Detailed Description:

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.

  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 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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006036

Locations
Canada, British Columbia
British Columbia Cancer Agency    
      Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre    
      Hamilton, Ontario, Canada, L8V 5C2
Toronto General Hospital    
      Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators
National Cancer Institute of Canada

Investigators
Study Chair:     Hal W. Hirte, MD, FRCP(C)     Margaret and Charles Juravinski Cancer Centre    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000068051, CAN-NCIC-IND133, NEXSTAR-110-05
First Received:   July 5, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006036
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer  
stage III ovarian epithelial cancer  
stage IV ovarian epithelial cancer  
recurrent ovarian epithelial cancer  
extensive stage small cell lung cancer  
recurrent small cell lung cancer  
stage IV nasopharyngeal cancer  
stage IIIA non-small cell lung cancer  
stage IIIB non-small cell lung cancer  
stage IV non-small cell lung cancer  
unspecified adult solid tumor, protocol specific  
untreated metastatic squamous neck cancer with occult primary  
recurrent metastatic squamous neck cancer with occult primary  
ovarian stromal cancer  
stage III ovarian germ cell tumor  
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor
stage III squamous cell carcinoma of the lip and oral cavity
stage III basal cell carcinoma of the lip
stage III verrucous carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV basal cell carcinoma of the lip
stage IV verrucous carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent basal cell carcinoma of the lip
recurrent verrucous carcinoma of the oral cavity

Study placed in the following topic categories:
Thoracic Neoplasms
Lurtotecan
Gonadal Disorders
Squamous cell carcinoma
Malignant mesenchymal tumor
Sodium Salicylate
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Adenoid cystic carcinoma
Soft tissue sarcomas
Genital Diseases, Female
Cisplatin
Carcinoma, Adenoid Cystic
Respiratory Tract Diseases
Lung Neoplasms
Metastatic squamous neck cancer with occult primary
Carcinoma, squamous cell
Laryngeal carcinoma
Papilloma
Endocrine Gland Neoplasms
Ovarian cancer
Non-small cell lung cancer
Ovarian Neoplasms
Salicylsalicylic acid
Genital Neoplasms, Female
Endocrine System Diseases
Carcinoma, Basal Cell
Granuloma
Recurrence

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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