Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00087048
First received: July 8, 2004
Last updated: December 17, 2013
Last verified: October 2006
  Purpose

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

PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: topotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and toxic effects [ Designated as safety issue: Yes ]
  • Recurrence-free survival [ Designated as safety issue: No ]
  • Time to response and tumor response [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: April 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the overall survival of patients with recurrent extensive stage small cell lung cancer treated with high-dose topotecan hydrochloride.

Secondary

  • Determine the safety and toxic effects of this drug in these patients.
  • Determine the recurrence-free survival of patients treated with this drug.
  • Determine time to response and tumor response in patients treated with this drug.
  • Determine the quality of life of patients treated with this drug.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive high-dose topotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, day 1 of each course (except course 1), at the end of study treatment, and then every 3 months thereafter.

Patients are followed at 7-14 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed small cell lung cancer (SCLC)

    • Recurrent extensive stage disease
    • No mixed histology
  • Measurable disease

    • At least 1 bidimensionally measurable, non-CNS, indicator lesion confirmed by CT scan or MRI
  • Sensitive disease

    • Responded to prior first-line therapy AND relapsed ≥ 60 days after response (90 days after initiation of first-line therapy)
  • Eligible for high-dose chemotherapy
  • No symptomatic brain metastases affecting performance status

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 2 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Hematocrit > 35% (without transfusion)

Hepatic

  • SGOT and SGPT ≤ 2 times normal*
  • Alkaline phosphatase ≤ 2 times normal*
  • Bilirubin ≤ 2.0 mg/dL
  • Albumin > 2.5 g/dL
  • Hepatitis B surface antigen negative
  • No significant hepatic disease NOTE: *≤ 5 times upper limit of normal if liver metastases are present

Renal

  • Creatinine clearance ≥ 40 mL/min

Cardiovascular

  • No history of cardiac arrhythmias
  • No congestive heart failure
  • No ischemic heart disease
  • No stroke or other embolic disease requiring daily treatment that would preclude study participation

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • HIV negative
  • No known seizure disorder
  • No active infection requiring systemic therapy within the past 2 weeks
  • No known hypersensitivity to topotecan hydrochloride
  • No medical or psychiatric condition that would preclude study participation
  • No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy
  • No more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for SCLC
  • No prior topotecan hydrochloride

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 2 months since prior investigational agent
  • No other concurrent investigational agent
  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: NCT00087048

Locations
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Afshin Dowlati, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00087048     History of Changes
Other Study ID Numbers: CDR0000372872, CASE-HFHS-1503, HFH-HFHS-1503, HFH-HFHS-0205, CWRU-050308
Study First Received: July 8, 2004
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
extensive stage small cell lung cancer
recurrent small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Topotecan
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014