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Lung CancerPhase 3NCT00041015

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

A Phase 3 study testing cisplatin, etoposide and topotecan hydrochloride in people with Lung Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
cisplatin, etoposide and topotecan hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
Sep 2001to Nov 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed extensive stage small cell lung carcinoma (SCLC)
  • No prior chemotherapy for SCLC OR
  • No chemotherapy within 5 years of diagnosis of SCLC
  • Prior radiotherapy to measurable or nonmeasurable disease field allowed provided radiotherapy was completed at least 6 weeks ago and the disease is demonstrated to be progressing
  • No clinical signs or symptoms of brain and/or leptomeningeal metastases by CT scan or MRI
  • Brain and/or leptomeningeal metastases that are asymptomatic on neurologic exam are allowed provided metastases do not require corticosteroid therapy to control symptoms

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Hemoglobin at least 9.0 g/dL
  • WBC at least 3,500/mm3
  • Platelet count at least 100,000/mm3
  • Neutrophil count at least 1,500/mm3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • SGOT and SGPT no greater than 2 times the upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver metastases present)

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • No pre-existing renal impairment that would preclude cisplatin use

Gastrointestinal:

  • No clinical evidence of any gastrointestinal (GI) conditions including:
  • Removal of a portion of the stomach
  • History of recent obstruction of the GI tract
  • GI autonomic neuropathy
  • Ulcerative colitis
  • Crohn's disease
  • Malabsorption syndrome
  • Treatment with cyclosporine that would alter absorption or GI motility
  • No other conditions that would preclude absorption of oral topotecan

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 3 months prior to study, during, and for at least 1 month after study
  • No active infection
  • No other prior or concurrent malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or localized low-grade prostate cancer
  • No other concurrent severe medical problems that would expose the patient to extreme risk or preclude study compliance
  • No prior allergic reactions to compounds chemically related to study drugs
  • No pre-existing hearing impairment that would preclude cisplatin use
  • No overall medical condition for which study drugs would be inappropriate

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy for SCLC

Chemotherapy:

  • See Disease Characteristics
  • No other concurrent chemotherapy for SCLC

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent hormonal therapy for SCLC

Radiotherapy:

  • See Disease Characteristics
  • At least 24 hours since prior radiotherapy with no expected bone marrow suppression
  • Recovered from prior palliative radiotherapy (e.g, nausea and vomiting from radiation of the epigastrium)
  • No concurrent radiotherapy for SCLC
  • No concurrent radiotherapy for palliation of bone metastases or CNS lesions unless approved by the investigator

Surgery:

  • At least 3 weeks since prior major surgery (a shorter period is allowed if deemed in the best interest of the patient)

Other:

  • More than 30 days or 5 half-lives (whichever is longer) since prior investigational drugs
  • No other concurrent investigational therapy for SCLC
  • No concurrent cyclosporine
  • No concurrent drugs that would preclude absorption of oral topotecan

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

Other trials in United States

About this study

Official title: An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin As Treatment For Chemotherapy-Naive Patients With Extensive Disease - Small Cell Lung

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 may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer.

PURPOSE: Randomized phase III trial to compare different chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.

Read the detailed description

OBJECTIVES:

  • Compare the overall survival of patients with chemotherapy-naive extensive stage small cell lung cancer treated with cisplatin and oral topotecan vs cisplatin and etoposide.
  • Compare the response rates, response duration, and time to progression in patients treated with these regimens.
  • Compare the tolerability of these regimens in these patients.
  • Compare the patient-perceived disease status and well being in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, ECOG performance status (0 vs 1 vs 2), lactate dehydrogenase (less than 1.5 times upper limit of normal (ULN) vs 1.5 times ULN or greater), and country. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral topotecan once daily on days 1-5 and cisplatin IV on day 5.
  • Arm II: Patients receive cisplatin IV on day 1 and etoposide IV over at least 30 minutes on days 1-3.

Treatment in both arms repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, prior to each course, at 4 weeks after study, and then every 4 weeks for 16 weeks.

Patients are followed at 4 weeks, every 4 weeks for 16 weeks, and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 760 patients (380 per treatment arm) will be accrued for this study within 18 months.

Conditions
Lung Cancer
Being tested
cisplatin, etoposide, topotecan hydrochloride
Keywords
extensive stage small cell lung cancer, recurrent small cell lung cancer
Medical subject headings
Lung Neoplasms, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00041015
Study groupRoleWhat they receive
oral topotecan plus cisplatin IVActive comparatororal topotecan once daily on days 1-5 and cisplatin IV on day 5
Receives: Drug: cisplatin; Drug: topotecan hydrochloride
Cisplatin IV plus etoposide IVExperimentalCisplatin IV on day 1 and etoposide IV over at least 30 minutes
Receives: Drug: cisplatin; Drug: etoposide

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 2001
  3. Primary completionNov 2002
  4. Study completionNov 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00041015
Sponsor's protocol ID
SKF1501
Other IDs
CWRU-070144, SB-389, SB-SKF-104864A, SB-SKF-1501, NCI-G02-2092
Status last verified
Jan 2014
First submitted
8 Jul 2002
Last updated
9 Jan 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, etoposide and topotecan hydrochloride in people with Lung Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.

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