Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

September 7, 2021 updated by: Wake Forest University Health Sciences

Phase II Study of Sequential Topotecan-Carboplatin-Etoposide in Patients With Extensive Stage Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining topotecan, carboplatin, and etoposide in treating patients who have extensive-stage small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the toxicity profile and maximum tolerated dose of sequential topotecan, carboplatin, and etoposide in patients with chemotherapy-naive extensive stage small cell lung cancer. (Phase I closed to accrual as of 04/04/2003).
  • Determine the response rate and duration of response in patients with treated with this regimen.
  • Determine the failure-free and overall survival of patients treated with this regimen.
  • Determine the pharmacokinetics and pharmacodynamics of topotecan and etoposide on this schedule in these patients.

OUTLINE: This is a dose-escalation, multicenter study of topotecan and etoposide. (Phase I closed to accrual as of 04/04/2003).

Patients receive oral topotecan on days 1-5, carboplatin IV over 30 minutes on day 6, and oral etoposide on days 6-10. Treatment continues every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response after the second course receive up to 4 additional courses. Patients with brain metastases at initial presentation undergo whole-brain irradiation before the chemotherapy regimen. Patients without brain metastases at initial presentation who achieve CR undergo prophylactic whole-brain irradiation.

Sequential dose escalation of topotecan is followed by sequential dose escalation of etoposide. Cohorts of 3-6 patients receive escalating doses of topotecan and then etoposide until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. (Phase I closed to accrual as of 04/04/2003). In the phase II part of study, an additional 11-40 patients are accrued to receive topotecan, carboplatin, and etoposide at the MTD.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A maximum of 50 patients (3-10 for phase I and 11-40 for phase II) will be accrued for this study. (Phase I closed to accrual as of 04/04/2003)

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534-9479
        • Southeastern Medical Oncology Center
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
    • Virginia
      • Richmond, Virginia, United States, 23298-0037
        • MBCCOP - Massey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed extensive stage small cell lung cancer

  • Measurable or evaluable disease

    • Pleural effusions allowed, but not considered measurable or evaluable disease
  • Brain metastases allowed provided neurologically stable at study entry

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 2 months

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine no greater than 1.5 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to swallow capsules
  • No concurrent or prior malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • No other serious medical or psychiatric illness that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior radiotherapy for brain metastasis allowed
  • No other prior radiotherapy
  • No other concurrent radiotherapy

Surgery:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate

Secondary Outcome Measures

Outcome Measure
Duration of response
Failure-free and overall survival
Pharmacokinetics and pharmacodynamics of topotecan and etoposide

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Antonius A. Miller, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2001

Primary Completion (Actual)

January 18, 2005

Study Completion (Actual)

January 18, 2005

Study Registration Dates

First Submitted

October 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REBACDR0000068945
  • CCCWFU-62300
  • NCI-5333

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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