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

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00010218

Purpose

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 karenitecin in treating patients who have relapsed or refractory non-small cell lung cancer

Condition	Intervention	Phase
Lung Cancer	Drug: karenitecin	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase II Trial Of Karenitecin (IND 57250) In Patients With Relapsed or Refractory Non-small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Karenitecin

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Enrollment:	55
Study Start Date:	April 2001
Study Completion Date:	January 2006
Primary Completion Date:	April 2003 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the response rate and duration of response in patients with relapsed or refractory non-small cell lung cancer treated with karenitecin as salvage chemotherapy.
Determine the effect of prior response to chemotherapy on response to this drug in these patients.
Determine survival and failure-free survival of patients treated with this drug.
Determine the toxicity profile of this drug in these patients.

OUTLINE: Patients are stratified according to response to prior chemotherapy (relapsed vs refractory).

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.

PROJECTED ACCRUAL: A minimum of 45 patients (25 for stratum I and 20 for stratum II) will be accrued for this study within 12 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010218

Show 44 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Antonius A. Miller, MD

Comprehensive Cancer Center of Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2005 Jan 23.

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.

Responsible Party:	Monica M Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00010218 History of Changes
Other Study ID Numbers:	CDR0000068456, U10CA031946, CLB-30004
Study First Received:	February 2, 2001
Last Updated:	March 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cancer and Leukemia Group B:

recurrent non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer

adenocarcinoma of the lung
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012