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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Antonius A. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068456

NCT ID:

NCT00010218

Start Date:

April 2001

Completion Date:

January 2006

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Lombardi Cancer CenterWashington, District of Columbia  20007
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Weill Medical College of Cornell UniversityNew York, New York  10021
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722