Clinical trial NCT00022711: Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer
Official title: A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients With Relapsed Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: recurrent small cell lung cancer
intermediate type small cell lung cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 7
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 use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have relapsed or progressive small cell lung cancer.

Detailed description: OBJECTIVES:

* Determine the efficacy of temozolomide, in terms of response rate and safety, in patients with relapsed or progressive small cell lung cancer.
* Determine the time to progression and overall survival in patients treated with this drug.
* Assess quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior chemotherapy (chemosensitive at least 60 days after prior therapy vs chemoresistant less than 60 days after or progression during prior therapy).

Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed prior to each course of chemotherapy, at 30 days after study completion, and then every 8 weeks thereafter.

Patients are followed at 30 days and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 37-79 patients (14-33 chemosensitive and 23-46 chemoresistant) will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed relapsed or progressive small cell lung cancer

  * Classical or intermediate variant OR
  * Relapsed or progressive extrapulmonary small cell carcinoma of unknown origin
* Bidimensionally measurable disease

  * At least 1 cm by 1 cm by physical exam or radiologic exam
  * Outside prior radiation port unless clinical evidence of disease progression
* Previously radiated brain metastases allowed provided stable or improved

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* More than 12 weeks

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3

Hepatic:

* Bilirubin no greater than 2 times upper limit of normal (ULN)
* SGOT/SGPT no greater than 3 times ULN (5 times ULN if liver metastases present)
* Alkaline phosphatase no greater than 5 times ULN

Renal:

* Creatinine no greater than 2 mg/dL

Other:

* HIV negative
* No AIDS-related illness
* No frequent vomiting or medical condition that would interfere with oral medication administration (e.g., partial bowel obstruction)
* No active nonmalignant systemic disease that would preclude study
* No other active invasive malignancy within the past year or concurrently requiring ongoing treatment
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for at least 1 month before, during, and for at least 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior biologic therapy
* No concurrent immunotherapy
* No concurrent biologic therapy
* Concurrent epoetin alfa allowed

Chemotherapy:

* At least 4 weeks since prior chemotherapy
* No more than 1 prior continuous or discontinuous chemotherapy regimen for metastatic disease
* No other concurrent chemotherapy

Endocrine therapy:

* Concurrent hormonal therapy to boost appetite allowed (e.g., corticosteroids or medroxyprogesterone)

Radiotherapy:

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy to 15% or more of bone marrow
* At least 1 week since prior radiotherapy to less than 15% of bone marrow
* No prior radiotherapy to 50% or more of bone marrow
* No concurrent radiotherapy

Surgery:

* Not specified

Other:

* Recovered from prior therapy
* No other concurrent investigational drugs
* Concurrent pamidronate allowed

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Flemington
country: United States
facility: Hunterdon Regional Cancer Center
state: New Jersey
city: Lakewood
country: United States
facility: Kimball Medical Center
state: New Jersey
city: Millville
country: United States
facility: South Jersey Regional Cancer Center
state: New Jersey
city: Mount Holly
country: United States
facility: Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center - Booker Cancer Center
state: New Jersey
city: Toms River
country: United States
facility: Community Medical Center
state: New Jersey
city: Trenton
country: United States
facility: St. Francis Medical Center
state: New Jersey
city: Altoona
country: United States
facility: Bon Secours-Holy Family Health System
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Delaware County Memorial Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health Hospitals
state: Pennsylvania
city: Johnstown
country: United States
facility: Conemaugh Memorial Hospital
state: Pennsylvania
city: Langhorne
country: United States
facility: Saint Mary Regional Center
state: Pennsylvania
city: Lansdale
country: United States
facility: Central Montgomery Medical Center
state: Pennsylvania
city: Paoli
country: United States
facility: Paoli Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pottstown
country: United States
facility: Pottstown Memorial Regional Cancer Center
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Corey J. Langer, MD
role: STUDY_CHAIR
References: