Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
Condition: Head and Neck Cancer; Lung Cancer; Ovarian Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Lung Neoplasms; Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

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.
    

Intervention name(s): cisplatin; lurtotecan liposome
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lurtotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 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; recurrent mucoepidermoid carcinoma of the oral cavity; recurrent adenoid cystic carcinoma of the oral cavity; stage III squamous cell carcinoma of the oropharynx; stage III lymphoepithelioma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage IV lymphoepithelioma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; recurrent lymphoepithelioma of the oropharynx; stage III squamous cell carcinoma of the nasopharynx; stage III lymphoepithelioma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; stage IV lymphoepithelioma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; recurrent lymphoepithelioma of the nasopharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; recurrent verrucous carcinoma of the larynx; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage III inverted papilloma of the paranasal sinus and nasal cavity; stage III midline lethal granuloma of the paranasal sinus and nasal cavity; stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV inverted papilloma of the paranasal sinus and nasal cavity; stage IV midline lethal granuloma of the paranasal sinus and nasal cavity; stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent inverted papilloma of the paranasal sinus and nasal cavity; recurrent midline lethal granuloma of the paranasal sinus and nasal cavity; recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity; borderline ovarian surface epithelial-stromal tumor; ovarian sarcoma