Combination Chemotherapy in Treating Patients With Extensive-Stage 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. Combining more than one drug and giving them in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining topotecan, carboplatin, and etoposide in treating patients who have extensive-stage small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: etoposide Drug: topotecan hydrochloride Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Sequential Topotecan-Carboplatin-Etoposide in Patients With Extensive Stage Small Cell Lung Cancer |
- Response rate [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Failure-free and overall survival [ Designated as safety issue: No ]
- Pharmacokinetics and pharmacodynamics of topotecan and etoposide [ Designated as safety issue: No ]
| Study Start Date: | November 2001 |
OBJECTIVES:
- Determine the toxicity profile and maximum tolerated dose of sequential topotecan, carboplatin, and etoposide in patients with chemotherapy-naive extensive stage small cell lung cancer. (Phase I closed to accrual as of 04/04/2003).
- Determine the response rate and duration of response in patients with treated with this regimen.
- Determine the failure-free and overall survival of patients treated with this regimen.
- Determine the pharmacokinetics and pharmacodynamics of topotecan and etoposide on this schedule in these patients.
OUTLINE: This is a dose-escalation, multicenter study of topotecan and etoposide. (Phase I closed to accrual as of 04/04/2003).
Patients receive oral topotecan on days 1-5, carboplatin IV over 30 minutes on day 6, and oral etoposide on days 6-10. Treatment continues every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response after the second course receive up to 4 additional courses. Patients with brain metastases at initial presentation undergo whole-brain irradiation before the chemotherapy regimen. Patients without brain metastases at initial presentation who achieve CR undergo prophylactic whole-brain irradiation.
Sequential dose escalation of topotecan is followed by sequential dose escalation of etoposide. Cohorts of 3-6 patients receive escalating doses of topotecan and then etoposide until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. (Phase I closed to accrual as of 04/04/2003). In the phase II part of study, an additional 11-40 patients are accrued to receive topotecan, carboplatin, and etoposide at the MTD.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A maximum of 50 patients (3-10 for phase I and 11-40 for phase II) will be accrued for this study. (Phase I closed to accrual as of 04/04/2003)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed extensive stage small cell lung cancer
Measurable or evaluable disease
- Pleural effusions allowed, but not considered measurable or evaluable disease
- Brain metastases allowed provided neurologically stable at study entry
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 2 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to swallow capsules
- No concurrent or prior malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix
- No other serious medical or psychiatric illness that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Prior radiotherapy for brain metastasis allowed
- No other prior radiotherapy
- No other concurrent radiotherapy
Surgery:
- Not specified
Contacts and Locations| United States, North Carolina | |
| Southeastern Medical Oncology Center | |
| Goldsboro, North Carolina, United States, 27534-9479 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Virginia | |
| MBCCOP - Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Study Chair: | Antonius A. Miller, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00025272 History of Changes |
| Other Study ID Numbers: | CDR0000068945, CCCWFU-62300, NCI-5333 |
| Study First Received: | October 11, 2001 |
| Last Updated: | August 20, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Wake Forest University Baptist Medical Center:
|
extensive stage 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 Etoposide |
Etoposide phosphate Carboplatin Topotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013