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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
Not Enrolling
Lung Cancer

Thank you

Trial Information

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


- 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

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

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


- 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



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified


- Granulocyte count at least 1,500/mm3

- Platelet count at least 100,000/mm3


- Bilirubin no greater than 1.5 mg/dL


- Creatinine no greater than upper limit of normal


- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- 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


- 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


- See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Antonius A. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Food and Drug Administration

Study ID:




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



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