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Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This study has been completed.
Study NCT00061854   Information provided by National Cancer Institute (NCI)
First Received: June 5, 2003   Last Updated: July 23, 2008   History of Changes

June 5, 2003
July 23, 2008
April 2003
 
 
 
Complete list of historical versions of study NCT00061854 on ClinicalTrials.gov Archive Site
 
 
 
Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase II Study Of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, To Patients With Progressive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) Following Treatment With Platinum-Based Chemotherapy

RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have progressive locally advanced or metastatic non-small cell lung cancer.

OBJECTIVES:

  • Determine the objective tumor response rate and duration of response in patients with progressive locally advanced or metastatic non-small cell lung cancer treated with soblidotin as second-line therapy after receiving prior platinum-based chemotherapy.
  • Determine the time to tumor progression in patients treated with this drug.
  • Determine the median survival time and 12-month survival rate of patients treated with this drug.
  • Determine the quantitative and qualitative toxic effects of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Plasma sampling for pharmacokinetics is done on day 1 of course 1.

Patients are followed for survival every 3 months after discontinuing study treatment.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 1 year.

Phase II
Interventional
Treatment, Open Label
Lung Cancer
Drug: soblidotin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer

    • Locally advanced or metastatic disease
  • Demonstrates tumor progression
  • Must have received 1 prior chemotherapy regimen

    • Prior chemotherapy must have included a platinum agent
  • Measurable disease

    • At least 1 measurable lesion outside the field of any prior radiotherapy
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present)

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiac

  • Ejection fraction at least 40% by MUGA

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No psychiatric disorder that would preclude giving informed consent or following study instruction
  • No grade 2 or greater neurotoxicity
  • No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off therapy for that disease for at least 5 years prior to study entry
  • No other concurrent severe or uncontrolled underlying medical disease that would compromise patient safety and study outcome
  • No concurrent serious infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent anticancer biologic therapy

Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • No concurrent anticancer radiotherapy

    • Concurrent localized radiotherapy to a non-indicator lesion for pain relief is allowed provided other methods of pain control are ineffective

Surgery

  • At least 4 weeks since prior major surgery and recovered

Other

  • At least 4 weeks since prior myelosuppressive therapy
  • More than 28 days since prior investigational drugs
  • No other concurrent investigational drugs
  • No other concurrent anticancer cytotoxic therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00061854
 
CDR0000301749, DAIICHI-1027A-PRT005, MSKCC-03016
Daiichi Sankyo Inc.
 
Study Chair: Peter Cheverton, MD, ChB, MMED, RadT Daiichi Pharmaceuticals
National Cancer Institute (NCI)
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP