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CompletedPhase 2NCT00062010
Official study title

Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer

Study summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Giving interferon alfa and isotretinoin together with paclitaxel may reduce resistance to the drug and allow the tumor cells to be killed. PURPOSE: This phase II trial is studying how well giving interferon alfa and isotretinoin together with paclitaxel works in treating patients with recurrent small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedinterferon alpha and 13-cis-retinoic acid

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 7, 2023 · 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?73 U.S. locations

Locations may change over time.

Who runs it?Eastern Cooperative Oncology Group

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Eastern Cooperative Oncology Group
Interventions being studied
Biological: interferon alpha; Drug: 13-cis-retinoic acid; Drug: paclitaxel
02
Explore related studies

How this study is categorized

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

Cancer type
Small cell lung cancer (SCLC)→
Disease setting
Recurrent or relapsed→
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
  • Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) with clinically confirmed measurable disease
  • Age 18 and over
  • ECOG Performance status 0-3
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 1.5 mg/dL
  • AST no greater than 2 times upper limit of normal (ULN)
  • Creatinine no greater than 1.5 mg/dL
  • Triglycerides no greater than 1.5 times ULN
  • Patients must have had prior chemotherapy treatment for SCLC, and toxicities must have resolved to less than or equal to grade 1
  • Women of childbearing potential and sexually active males are strongly encouraged to use an accepted and effective method of contraception.
Reasons someone may not be able to joinExclusion criteria
  • History of another neoplasm other than SCLC except for non-metastatic, non-melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy at least 5 years before registration
  • Pregnant or nursing, with a negative pregnancy test within 2 weeks prior to registration
  • Severe depression requiring medication
  • Use of the following drugs within 4 weeks prior to registration: carbamazepine, ethanol, tetracycline, doxycycline, minocycline, topical acne products containing Retin-A, vitamin A, cisplatin, ketoconazole, phenytoin or other antiepileptic drugs
  • Use of GM-CSF or G-CSF within 4 weeks prior to registration
  • Prior paclitaxel or interferon therapy
  • Radiation therapy within 60 days prior to registration
  • Chemotherapy within 60 days prior to registration

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

  • Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia
  • Rush-Copley Cancer Care CenterAurora, Illinois
  • Hinsdale Hematology Oncology AssociatesHinsdale, Illinois
  • Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois
  • Swedish-American Regional Cancer CenterRockford, Illinois
  • Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois
  • CCOP - Carle Cancer CenterUrbana, Illinois
  • Elkhart General HospitalElkhart, Indiana
  • Howard Community HospitalKokomo, Indiana
  • Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana
  • Saint Anthony Memorial Health CentersMichigan City, Indiana
  • CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 7, 2023. Always confirm current availability with the study team.

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