Clinical trial · Interventional
Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Phase II Study of Carboplatin, Irinotecan, and Thalidomide in Patients With Advanced Non-Small Cell Lung Cancer
NCT00025285CI-TRIAL-00053785completedPhase 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: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining thalidomide with chemotherapy may kill more tumor cells and be an effective treatment for stage IIIB or stage IV non-small cell lung cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus thalidomide in treating patients who have stage IIIB or stage IV 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed stage IIIB (malignant pleural effusion) or stage IV non-small cell lung cancer
* Squamous cell carcinoma
* Basaloid carcinoma
* Adenocarcinoma
* Bronchoalveolar carcinoma
* Adenosquamous carcinoma
* Large cell carcinoma
* Large cell neuroendocrine carcinoma
* Giant cell carcinoma
* Sarcomatoid carcinoma
* Non-small cell carcinoma not otherwise specified
* Measurable disease
* At least 1 unidimensionally measurable lesion
* At least 20 mm by conventional techniques OR
* At least 10 mm by spiral CT scan
* The following lesions are considered nonmeasurable:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural or pericardial effusions
* Abdominal masses unconfirmed by imaging techniques
* Cystic lesions
* Previously irradiated brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
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 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 2 methods of effective contraception 4 weeks prior to, during, and for at least 4 weeks after thalidomide
* No prior seizures
* No other concurrent or prior malignancy within the past 5 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other serious medical or psychiatric illness that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy except steroids for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes) or intermittent dexamethasone as an antiemetic
Radiotherapy:
* Prior radiotherapy for brain metastasis allowed if neurologically stable and off steroids
* No concurrent palliative radiotherapy
Surgery:
* Not specifiedReferences
Publications (0)
Data not yet available
No reference posted for this study.