Nitrocamptothecin in Treating Patients With Advanced 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 advanced small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: rubitecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On - 2 Days Off" Oral Treatment in Advanced Small Cell Lung Cancer |
| Enrollment: | 38 |
| Study Start Date: | May 2000 |
| Primary Completion Date: | August 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the objective response and duration of objective response in patients with advanced small cell lung cancer treated with nitrocamptothecin.
- Determine the probability of objective response as expressed by the response rate in patients treated with this regimen.
- Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease status (sensitive vs refractory).
Patients receive oral nitrocamptothecin daily for 5 consecutive days each week for 3 weeks. Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD) receive up to 4 additional courses past SD. Patients who achieve partial response (PR) or complete response (CR) receive a minimum of 2 additional courses past CR or PR.
Patients are followed every 6 weeks until disease progression or initiation of another antitumor treatment.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for the sensitive disease stratum and a total of 19-24 patients will be accrued for the refractory disease stratum
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven advanced (extensive stage) small cell lung cancer with progressive or recurrent disease after 1 first line chemotherapy regimen
- Sensitive disease, defined as a response to prior chemotherapy lasting at least 3 months from the end of all prior treatment, including radiotherapy, until the time of progression OR
- Refractory disease, defined as no response to prior chemotherapy, or a response to prior chemotherapy followed by progression within 3 months after completion of all prior therapy, including radiotherapy
Minimum of 1 target lesion that can be accurately measured in at least 1 dimension
- 20 mm or more with conventional techniques OR
- 10 mm or more with spiral CT scans
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase, SGOT, and SGPT no greater than 2.5 time ULN (no greater than 5 times ULN if hepatic metastases present)
Renal:
- Creatinine no greater than 1.7 mg/dL
Cardiovascular:
- No ischemic heart disease within the past 6 months
- Normal 12 lead electrocardiogram
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior or concurrent malignancy except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer
- No unstable systemic disease or active uncontrolled infection
- No psychological, familial, sociological, or geographical condition that may preclude compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior maintenance therapy with biologic agents following first line chemotherapy allowed
- No concurrent filgrastim (G-CSF) with nitrocamptothecin
Chemotherapy:
- See Disease Characteristics
- Greater than 4 weeks since prior chemotherapy
- No more than 1 prior chemotherapy regimen for extensive disease
- Alternate or sequential use of different regimens without interruption in first line treatment is considered 1 first line therapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- Greater than 4 weeks since prior radiotherapy
Surgery:
- Greater than 2 weeks since prior major surgery
Other:
- No other concurrent anticancer therapy
- No other concurrent investigational therapy
Contacts and Locations| France | |
| CRLCC Nantes - Atlantique | |
| Nantes-Saint Herblain, France, 44805 | |
| Study Chair: | Pierre Fumoleau, MD, PhD | Centre de Lutte Contre le Cancer Georges-Francois Leclerc |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00006082 History of Changes |
| Other Study ID Numbers: | EORTC-16996SL, EORTC-16996SL |
| Study First Received: | August 3, 2000 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
extensive stage small cell lung cancer recurrent small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms 9-nitrocamptothecin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013