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

Lung Cancer Clinical Trial

Official title:

Phase II Trial Of Karenitecin (IND 57250) In Patients With Relapsed or Refractory Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00010218
• Other study ID #: CALGB-30004
• Secondary ID: U10CA031946CLB-3
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2001
• Last updated: July 15, 2016
• Start date: April 2001
• Est. completion date: January 2006

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2006
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• karenitecin

Locations

Country	Name	City	State
United States	Marlene and Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Green Mountain Oncology Group	Bennington	Vermont
United States	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Veterans Affairs Medical Center - Buffalo	Buffalo	New York
United States	Vermont Cancer Center	Burlington	Vermont
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Veterans Affairs Medical Center - Durham	Durham	North Carolina
United States	Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	North Shore University Hospital	Manhasset	New York
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mount Sinai Medical Center, NY	New York	New York
United States	Weill Medical College of Cornell University	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Lifespan: The Miriam Hospital	Providence	Rhode Island
United States	MBCCOP - Massey Cancer Center	Richmond	Virginia
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Veterans Affairs Medical Center - San Francisco	San Francisco	California
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	State University of New York - Upstate Medical University	Syracuse	New York
United States	Veterans Affairs Medical Center - Syracuse	Syracuse	New York
United States	Lombardi Cancer Center	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont
United States	CCOP - Christiana Care Health Services	Wilmington	Delaware
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center - University Campus	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

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. — View Citation