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CompletedPhase 2NCT00025285
Official study title

Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcarboplatin and irinotecan hydrochloride

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 9, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Wake Forest University Health Sciences
Interventions being studied
Drug: carboplatin; Drug: irinotecan hydrochloride; Drug: thalidomide
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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 specified

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • CCOP - Central IllinoisDecatur, Illinois
  • Southeastern Medical Oncology CenterGoldsboro, North Carolina
  • Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina
  • CCOP - GreenvilleGreenville, South Carolina
  • CCOP - Upstate CarolinaSpartanburg, South Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 9, 2021. Always confirm current availability with the study team.

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