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CompletedPhase 2NCT00010218
Official study title

Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer

Study summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of karenitecin in treating patients who have relapsed or refractory 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 studiedkarenitecin

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Recurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 19, 2016 · 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?44 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Drug: karenitecin
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
Recurrent or relapsed→Resistant or refractory→
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 relapsed or refractory non-small cell lung carcinoma (NSCLC)
  • Squamous cell carcinoma
  • Basaloid carcinoma
  • Adenocarcinoma
  • Bronchoalveolar carcinoma
  • Adenosquamous cell carcinoma
  • Large cell carcinoma
  • Large cell neuroendocrine carcinoma
  • Giant cell carcinoma
  • Sarcomatoid carcinoma
  • Non-small cell carcinoma not otherwise specified
  • Histologic or cytologic documentation of recurrence required if disease previously completely resected
  • Must have had only 1 prior chemotherapy regimen, including adjuvant or neoadjuvant therapy for NSCLC
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm with conventional techniques OR
  • At least 10 mm with spiral CT scan
  • Lesions that are not considered measurable include the following:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Abdominal masses not confirmed and followed by imaging techniques
  • Cystic lesions
  • Tumor lesions in a previously irradiated area
  • Controlled CNS metastases allowed if patient is neurologically stable and off steroids PATIENT CHARACTERISTICS: Age:
  • 18 and over Performance status:
  • ECOG 0-1 Life expectancy:
  • Not specified Hematopoietic:
  • Granulocyte 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 upper limit of normal Other:
  • Not pregnant or nursing
  • Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy:
  • Not specified Chemotherapy:
  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin)
  • No prior irinotecan or other camptothecin drug
  • No other concurrent chemotherapy Endocrine therapy:
  • See Disease Characteristics
  • No concurrent hormonal therapy except for non-cancer-related conditions (e.g., insulin for diabetes)
  • No concurrent steroids except for adrenal failure Radiotherapy:
  • See Disease Characteristics
  • Prior radiotherapy for symptomatic lesions or those that might produce disability (e.g., painful bone metastases) allowed if other measurable disease present
  • At least 4 weeks since prior radiotherapy
  • No concurrent palliative radiotherapy Surgery:
  • See Disease Characteristics

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

  • Rebecca and John Moores UCSD Cancer CenterLa Jolla, California
  • Veterans Affairs Medical Center - San FranciscoSan Francisco, California
  • UCSF Comprehensive Cancer CenterSan Francisco, California
  • CCOP - Christiana Care Health ServicesWilmington, Delaware
  • Lombardi Cancer CenterWashington D.C., District of Columbia
  • Walter Reed Army Medical CenterWashington D.C., District of Columbia
  • CCOP - Mount Sinai Medical CenterMiami Beach, Florida
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois
  • University of Chicago Cancer Research CenterChicago, Illinois
  • CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana
  • Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa
  • Holden Comprehensive Cancer CenterIowa City, Iowa

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 19, 2016. Always confirm current availability with the study team.

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