NCT00022711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline
Completed

Started Jan 2002

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2001

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

2 years

First QC Date

August 10, 2001

Last Update Submit

July 10, 2013

Conditions

Lung Cancer

Keywords

recurrent small cell lung cancerintermediate type small cell lung cancer

Study Arms (1)

Temozolomide

EXPERIMENTAL

Temozolomide 150mg/m2/day daily. Repeat cycles every 28days for maximum of six months

Drug: temozolomide

Interventions

temozolomideDRUG

150 mg/m2/day Repeat cycles every 28 days following first daily dose of each cycle until toxicity or disease progression for a maximum of six months

Temozolomide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (17)

Hunterdon Regional Cancer Center

Flemington, New Jersey, 08822, United States

Location

Kimball Medical Center

Lakewood, New Jersey, 08701, United States

Location

South Jersey Regional Cancer Center

Millville, New Jersey, 08332, United States

Location

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, 08060, United States

Location

Riverview Medical Center - Booker Cancer Center

Red Bank, New Jersey, 07701, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

St. Francis Medical Center

Trenton, New Jersey, 08629, United States

Location

Bon Secours-Holy Family Health System

Altoona, Pennsylvania, 16602, United States

Location

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026-1186, United States

Location

Pinnacle Health Hospitals

Harrisburg, Pennsylvania, 17105-8700, United States

Location

Conemaugh Memorial Hospital

Johnstown, Pennsylvania, 15905, United States

Location

Saint Mary Regional Center

Langhorne, Pennsylvania, 19047, United States

Location

Central Montgomery Medical Center

Lansdale, Pennsylvania, 19446-1200, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301-1792, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Pottstown Memorial Regional Cancer Center

Pottstown, Pennsylvania, 19464, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsSmall Cell Lung Carcinoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Corey J. Langer, MD

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2001

First Posted

January 27, 2003

Study Start

January 1, 2002

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

US(17)