Clinical trial · Interventional
Combination Chemotherapy and Exisulind in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Phase II Study of Carboplatin, Etoposide, and Exisulind in Patients With Extensive Small Cell Lung Cancer
NCT00041054CI-TRIAL-00025067completedPhase 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. Exisulind may make tumor cells more sensitive to chemotherapy. Combining chemotherapy with exisulind may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with exisulind in treating patients who have extensive-stage 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| exisulind | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- carboplatin + etoposide + exisulind
- description
- Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 4 months for 2 years.
- interventionNames
- Drug: carboplatin
- Drug: etoposide
- Drug: exisulind
Primary outcomes (1)
- measure
- percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment
- timeFrame
- Up to 3 years
Secondary outcomes (1)
- measure
- response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed small cell lung cancer
* At least 1 unidimensionally measurable lesion
* At least 20 mm by conventional techniques OR
* At least 10 mm by spiral CT scan
* Lesions considered nonmeasurable include:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Tumor lesions situated in a previously irradiated area
* Must not be considered for combined chemotherapy and radiotherapy
* No active CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin normal
* AST no greater than 2 times ULN
* No clinically significant hepatic disease
Renal:
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 60 mL/min
* No clinically significant renal disease
Cardiovascular:
* No clinically significant cardiac disease
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No concurrent uncontrolled illness
* No known sensitivity to sulindac
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* No prior chemotherapy for small cell lung cancer
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal agents except:
* Steroids for adrenal failure
* Hormones for nondisease-related conditions (e.g., insulin for diabetes)
* Intermittent use of dexamethasone as an antiemetic
Radiotherapy:
* See Disease Characteristics
* At least 2 weeks since prior radiotherapy, including for palliation
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* More than 7 days since prior sulindac
* No concurrent sulindacReferences
Publications (2)
- RESULTGovindan R, Wang X, Baggstrom MQ, Burdette-Radoux S, Hodgson L, Vokes EE, Green MR; Cancer and Leukemia Group B. A phase II study of carboplatin, etoposide, and exisulind in patients with extensive small cell lung cancer: CALGB 30104. J Thorac Oncol. 2009 Feb;4(2):220-6. doi: 10.1097/JTO.0b013e3181951eb0. PMID 19179900
- DERIVEDHanna M, Thipphawong J; 118 Study Group. A randomized, double-blind comparison of OROS(R) hydromorphone and controlled-release morphine for the control of chronic cancer pain. BMC Palliat Care. 2008 Oct 31;7:17. doi: 10.1186/1472-684X-7-17. PMID 18976472