Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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 may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 3 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 5, 2023 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Eastern Cooperative Oncology Group
- Interventions being studied
- Biological: G-CSF; Drug: Cisplatin; Drug: Etoposide; Drug: Irinotecan; Drug: Topotecan
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
- Extensive stage small cell lung cancer (SCLC) with measurable disease, evaluated within 2 weeks prior to randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- Disease-free for \>=5 years if had a prior second malignancy other than treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
- Adequate hematologic, hepatic and renal function determined by the following tests, within 4 weeks prior to randomization: white blood cell (WBC) \>=4000/mm3 and platelets \>=100,000/mm3; bilirubin \<= upper limit of normal; serum glutamic pyruvate transaminase (SGPT) or alanine transaminase (ALT) and serum glutamic oxaloacetic transaminase (SGOT) or aspartate transaminase( AST) \<=2.5 x upper limit of normal if no demonstrable liver metastases or \<=5 times upper limit of normal in the presence of liver metastases; Calculated creatinine clearance \>=30 using the formulas in the protocol
- Age 18 and older
- Strongly advised to use an accepted and effective method of contraception
- Those with central nervous system (CNS) metastases were eligible if the metastases were treated without advancing symptoms prior to the initiation of chemotherapy
- Those receiving erythropoietin could continue to receive it
- Prior radiotherapy for lung cancer; Prior radiotherapy allowed only for central nervous system (CNS) metastases
- Prior chemotherapy for this disease
- Pregnant or lactating
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware
- CCOP - Christiana Care Health ServicesNewark, Delaware
- Baptist Cancer Institute - JacksonvilleJacksonville, Florida
- University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida
- Medical Center of Central GeorgiaMacon, Georgia
- Rush-Copley Cancer Care CenterAurora, Illinois
- Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois
- Hematology & Oncology CareMoline, Illinois
- Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia FieldsOlympia Fields, Illinois
- Swedish-American Regional Cancer CenterRockford, Illinois
- Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 5, 2023. Always confirm current availability with the study team.