Topotecan Hydrochloride and Doxorubicin Hydrochloride in Treating Relapsed or Refractory Small Cell Lung Cancer
A Phase I Study of Weekly Doxorubicin and Oral Topotecan for Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)
3 other identifiers
interventional
22
1 country
1
Brief Summary
This phase I trial studies the side effects and best dose of topotecan hydrochloride when given together with doxorubicin hydrochloride in treating patients with small cell lung cancer (SCLC) that has come back after a period of improvement (relapsed) or has not responded to treatment (refractory). Drugs used in chemotherapy, such as topotecan hydrochloride and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Doxorubicin hydrochloride may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving topotecan hydrochloride and doxorubicin hydrochloride may be a better treatment for small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2009
CompletedFirst Submitted
Initial submission to the registry
March 4, 2009
CompletedFirst Posted
Study publicly available on registry
March 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedSeptember 26, 2023
September 1, 2023
9 years
March 4, 2009
September 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose defined as the next lowest dose level below where greater than or equal to 2/3 or 3/6 patients experience dose limiting toxicities in cohorts of 5 different doses by National Cancer Institute Common Toxicity Criteria version 3.0
The actual rates of dose limiting toxicities per dose cohort will be presented when applicable.
Up to 6 weeks (after 2 courses)
Secondary Outcomes (3)
Changes in topoisomerase I and II levels in peripheral blood mononuclear cells
Baseline to up to week 16
Overall response rate
Up to 15 weeks (after 5 courses)
Changes in quality of life levels
Up to 16 weeks
Study Arms (1)
Treatment (doxorubicin hydrochloride, topotecan hydrochloride)
EXPERIMENTALPatients receive doxorubicin hydrochloride IV over 3-5 minutes on day 6 of course 1 and on days 6, 13, and 20 of courses 2-5. Patients also receive topotecan hydrochloride PO on days 1-5. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Correlative studies
Ancillary studies
Given PO
Eligibility Criteria
You may qualify if:
- Pathologically proven diagnosis of small cell lung cancer (SCLC)
- Have received at least one prior chemotherapy regimen for SCLC
- Primarily refractory or relapsed disease
- Measurable or evaluable disease: measurable disease in 2 dimensions on imaging studies performed within 4 weeks of starting treatment
- Greater than 2 weeks since last treatment (chemotherapy or radiation) provided subject has recovered from side effects of treatment prior to the study
- Karnofsky score \>= 70; (Eastern Cooperative Oncology Group \[ECOG\] 0-2)
- No active secondary malignancy; patients with other prior malignancies will be included, provided they have been disease-free for at least five years
- Patients with adequately treated basal cell or squamous cell carcinoma of the skin, adequately treated non-invasive carcinomas will be eligible
- White blood cell (WBC) count \>= 3,500/mm\^3 within 7 days prior to starting treatment, OR
- Absolute neutrophil count (ANC) \>= 1,500/ul within 7 days prior to starting treatment
- Platelet count \>= 100,000/mm\^3 within 7 days prior to starting treatment
- Serum creatinine less than 1.5 times the upper limits of normal within 7 days prior to starting treatment
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 1.5 times the upper limits of normal within 7 days prior to starting treatment in the absence of liver metastasis; in the presence of liver metastasis serum AST and ALT less than or equal to 5.0 times the upper limits of normal within 7 days prior to starting treatment
- Serum alkaline phosphatase less than 2.5 times the upper limits of normal within 7 days prior to starting treatment in the absence of liver metastasis; in the presence of liver metastasis serum alkaline phosphatase less than or equal to 5.0 times the upper limits of normal within 7 days prior to starting treatment
- Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study; (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
- +3 more criteria
You may not qualify if:
- Known hypersensitivity to any component of topotecan or doxorubicin or other required drugs in the study
- Any co morbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
- Ejection fraction below the lower limit of normal (\< 50%)
- Uncontrolled intercurrent illnesses including, but not limited to unstable angina or uncontrolled cardiac arrhythmia, chronic liver disease, complete left bundle branch block, obligate use of a cardiac pacemaker, ST depression of \> 1 mm in two or more leads and/or T wave inversions in two or more contiguous leads, congenital long QT syndrome, history of or presence of significant ventricular or atrial tachyarrhythmias, clinically significant resting bradycardia (\< 50 beats per minute), corrected QT (QTc) \> 480 ms on screening electrocardiogram that could jeopardize the patient?s ability to receive the chemotherapy described in the protocol safely
- Women who are pregnant (confirmed by a serum pregnancy test in females of reproductive potential) or breast-feeding; women of child-bearing potential and sexually active males must be advised to take precautions to prevent pregnancy during treatment (unless the subject or subject?s partner(s) is sterile (i.e. women who have had a hysterectomy or have been post-menopausal for at least twelve consecutive months) or remain abstinent, men and women of reproductive potential must agree to use TWO of the following forms of birth control every time they have sex throughout the study and for up to 3 months following discontinuation of study drug: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicidal, intrauterine device (IUD), or surgical sterilization while participating in this study; hormonal birth control methods are not permitted
- Inability to co-operate with the requirements of the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nebraskalead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Apar Ganti, MD
University of Nebraska
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2009
First Posted
March 5, 2009
Study Start
February 2, 2009
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
September 26, 2023
Record last verified: 2023-09