Conditions

Keywords

recurrent non-small cell lung cancersquamous cell lung cancerlarge cell lung canceradenocarcinoma of the lungadenosquamous cell lung cancerbronchoalveolar cell lung cancer

Study Arms (1)

karenitecin

EXPERIMENTAL

Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 6 courses may receive 2 additional courses beyond best response. Patients are followed every 3 months for 1 year and then every 6 months thereafter.

Drug: karenitecin

Interventions

karenitecinDrug

karenitecin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed relapsed or refractory non-small cell lung carcinoma (NSCLC) * Squamous cell carcinoma * Basaloid carcinoma * Adenocarcinoma * Bronchoalveolar carcinoma * Adenosquamous cell carcinoma * Large cell carcinoma * Large cell neuroendocrine carcinoma * Giant cell carcinoma * Sarcomatoid carcinoma * Non-small cell carcinoma not otherwise specified * Histologic or cytologic documentation of recurrence required if disease previously completely resected * Must have had only 1 prior chemotherapy regimen, including adjuvant or neoadjuvant therapy for NSCLC * At least 1 unidimensionally measurable lesion * At least 20 mm with conventional techniques OR * At least 10 mm with spiral CT scan * Lesions that are not considered measurable include the following: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Abdominal masses not confirmed and followed by imaging techniques * Cystic lesions * Tumor lesions in a previously irradiated area * Controlled CNS metastases allowed if patient is neurologically stable and off steroids PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 1.5 mg/dL Renal: * Creatinine no greater than upper limit of normal Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin) * No prior irinotecan or other camptothecin drug * No other concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * No concurrent hormonal therapy except for non-cancer-related conditions (e.g., insulin for diabetes) * No concurrent steroids except for adrenal failure Radiotherapy: * See Disease Characteristics * Prior radiotherapy for symptomatic lesions or those that might produce disability (e.g., painful bone metastases) allowed if other measurable disease present * At least 4 weeks since prior radiotherapy * No concurrent palliative radiotherapy Surgery: * See Disease Characteristics

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHcollaborator
Alliance for Clinical Trials in Oncology
Otherlead

Study Sites (44)

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

UCSF Comprehensive Cancer Center

San Francisco, California, 94143-0128, United States

CCOP - Christiana Care Health Services

Wilmington, Delaware, 19899, United States

Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

CCOP - Mount Sinai Medical Center

Related Publications (2)

Miller AA, Herndon JE 2nd, Gu L, Green MR; Cancer and Leukemia Group B. Phase II trial of karenitecin in patients with relapsed or refractory non-small cell lung cancer (CALGB 30004). Lung Cancer. 2005 Jun;48(3):399-407. doi: 10.1016/j.lungcan.2004.11.019. Epub 2005 Jan 23.
PMID: 15893009RESULT
Herndon JE, Miller AA, Zhang C, et al.: Phase II trial of karenitecin in patients with refractory non-small cell lung cancer (NSCLC): CALGB 30004 . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2706, 673, 2003.
RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of LungAdenocarcinoma, Bronchiolo-Alveolar

Interventions

cositecan

Condition Hierarchy (Ancestors)

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

Study Officials

Antonius A. Miller, MD
Wake Forest University Health Sciences
STUDY CHAIR

Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Study Arms (1)

karenitecin

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (44)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Study Arms (1)

karenitecin

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (44)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations