Clinical trial · Interventional
Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
Phase II Trial Of Karenitecin (IND 57250) In Patients With Relapsed or Refractory Non-small Cell Lung Cancer
NCT00010218CI-TRIAL-00023124completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| karenitecin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- karenitecin
- description
- 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.
- interventionNames
- Drug: karenitecin
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 CharacteristicsReferences
Publications (2)
- RESULTMiller 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. doi: 10.1016/j.lungcan.2004.11.019. Epub 2005 Jan 23. PMID 15893009
- RESULTHerndon 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.