Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00061854
First received: June 5, 2003
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: soblidotin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Study Start Date: April 2003
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061854

Locations
United States, Connecticut
Medical Oncology and Hematology, P.C.
Waterbury, Connecticut, United States, 06708
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
Study Chair: Peter Cheverton, MD, ChB, MMED, RadT Daiichi Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00061854     History of Changes
Other Study ID Numbers: CDR0000301749, DAIICHI-1027A-PRT005, MSKCC-03016
Study First Received: June 5, 2003
Last Updated: May 15, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Soblidotin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014