Nitrocamptothecin in Treating Patients With Recurrent 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 nitrocamptothecin in treating patients who have recurrent non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: rubitecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Study of RFS 2000 in Relapsed NSCLC |
| Study Start Date: | May 1999 |
OBJECTIVES: I. Determine the response rate, time to progression and overall survival of patients with recurrent non-small cell lung cancer when treated with nitrocamptothecin. II. Assess the toxicities and pharmacokinetics of this regimen in these patients.
OUTLINE: Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent non-small cell lung cancer No more than one prior chemotherapy treatment Bidimensionally measurable disease No prior radiotherapy to target lesion OR Progression since prior radiotherapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL ALT/AST no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver metastases) Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled serious medical or psychiatric illness
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No prior camptothecin Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Surgery: At least 2 weeks since prior major surgery
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00005872 History of Changes |
| Other Study ID Numbers: | CDR0000067908, SUPERGEN-RFS2000-16, DFCI-99184 |
| Study First Received: | June 2, 2000 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent non-small 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 9-nitrocamptothecin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013