Clinical trial NCT00087048: Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
Official title: The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: extensive stage small cell lung cancer
recurrent small cell lung cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-07-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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-central nervous system (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

* Eastern Cooperative Oncology Group (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

* Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (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

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Safety and toxic effects
measure: Recurrence-free survival
measure: Time to response and tumor response
measure: Quality of life
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Josephine Ford Cancer Center at Henry Ford Hospital
state: Michigan
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Afshin Dowlati, MD
role: STUDY_CHAIR
References: