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
Recruitment status was Active, not recruiting
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00087048
First received: July 8, 2004
Last updated: July 23, 2008
Last verified: October 2006
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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 |
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
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: | July 23, 2008 |
| 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 Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Topotecan Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013