Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
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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 2 |
| 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 |
| 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) |
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 |
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
Show 44 Study Locations| Study Chair: | Antonius A. Miller, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
Publications:
| 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 May 21, 2013