First-line Treatment Of Subjects With Extensive Disease Small Cell Lung Cancer With Weekly Hycamtin And Paraplatin

NCT00316186 | Completed Phase 2 Results

• 1 other identifier: 104864/903
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 13

Brief Summary

This study was designed to find the safest and most effective dose of a combination of two chemotherapy drugs, Hycamtin® (topotecan) and Paraplatin® (carboplatin), in people with extensive disease small cell lung cancer.

Conditions

Lung Cancer, Small Cell

Keywords

chemonaive; small cell lung cancer; untreated; Lung cancer; HYCAMTIN; first-line; extensive disease

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response

  The categories of tumor response were: complete response (complete disappearance of all known lesions determined by 2 measurements not less than 4 weeks apart), partial response (\>50% decrease in measurable lesions for at least 4 weeks with no appearance of new lesions), stable disease (no change in tumor size for at least 8 weeks), progressive disease (\>25% increase in measurements of lesions or appearance of new lesions), and not evaluable. The overall response rate was determined using a scan performed within the first 30 days of the first response.

  Baseline until up to Day 169

Secondary Outcomes (8)

• Time to Response

  From start of treatment to evidence of partial or complete response

• Response Duration

  From time of partial or complete response to disease progression/death

• Time to Progression

  From start of treatment to disease progression/death

• Overall Survival, Calculated as the Number of Subjects Who Died From the Start of Treatment Until Follow-up

  Week 1 up to maximum of Day 519

• Grade 1 (Mild) Hematological Toxicities

  Week 1 through Endpoint (variable based on disease progression or toxicity)

Study Arms (1)

Single arm, open label

EXPERIMENTAL

Drug: topotecan; Drug: carboplatin

Interventions

topotecan DRUG

Hycamtin and Carboplatin as first-line treatment of chemonaive subjects with EX-SCLC.

Single arm, open label

carboplatin DRUG

Hycamtin and Carboplatin as first-line treatment of chemonaive subjects with EX-SCLC.

Also known as: topotecan

Single arm, open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adequate contraception methods include: systemic contraceptives or IUD for 3 months prior to start of the study medication or diaphragm plus spermicide; for males, condom plus spermicide; or total abstinence from sexual intercourse during the course of the study
• Women of childbearing potential and sexually active males must practice or use an accepted and effective form of contraception
• Subjects who present with CNS metastases are eligible, provided the attending physician ascertains that the metastases are controlled before the start of chemotherapy, and the subject is asymptomatic on neurologic exam and is not receiving corticosteroid therapy to control symptoms. Continued use of other anti-seizure medication is permitted
• Free of active infection
• At screening, a probable life expectancy of at least 3 months
• No prior chemotherapy for SCLC or any chemotherapy within 5 years of the diagnosis of SCLC. Prior radiation to any symptomatic site is permitted provided that the indicator lesion site(s) are not irradiated, and radiation is completed before chemotherapy is started
• Performance status ECOG 0-1
• Adequate hematologic, renal and hepatic function •Hematologic: ANC 1500/mm3 \[1.5 x 109/L\], platelet count 100,000/L (100 x 109/L), hemoglobin 9.0 g/dL
• Renal: Serum Creatinine ≤1.5mg/dL (133mol/L) and CrCl 60 ml/min (Cockroft-Gault) \[Cockroft, 1976\]
• CrCl may be calculated using the Cockcroft-Gault formula:
• CrCl (ml/min) = Q x (140-age \[yr\]) x body wt \[kg\] 72 x serum creatinine \[mg/dl\] Q = 0.85 for females Q = 1.0 for males CrCl (ml/min) = K x (140-age \[yr\]) x body wt \[kg\] Serum creatinine \[mol/L\] K = 1.0 for females K = 1.23 for males
• Hepatic: Serum bilirubin (1.5 mg/dL), SGOT (AST), SGPT (ALT) and Alkaline Phosphatase 2 times the upper limit of normal (ULN) if liver metastases are absent by abdominal CT or MRI, or 5 times ULN if liver metastases are present
• At least 18 years old
• Written informed consent (subject's written understanding of and agreement to participate in this study.
• Subject with histologically-confirmed extensive small cell lung cancer or unequivocally positive positive cytological evidence (sputum, at least two, or aspirate biopsy)

You may not qualify if:

• Concurrent or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC. (Concurrent radiation for palliation of bone metastases and CNS lesions must be discussed with and approved by the GlaxoSmithKline Medical Monitor)
• Concurrent severe medical problems other than the diagnosis of SCLC, which would significantly limit full compliance with the study or expose the patient to extreme risk
• Concomitant malignancies or previous malignancies other than SCLC within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or localized low grade prostate cancer (contact GlaxoSmithKline Medical Monitor to discuss enrolment of subjects with low grade prostate cancer)
• Present clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan, or corticosteroid treatment to control symptoms of brain metastases
• Uncontrolled infection
• Ongoing tumor or previous tumor other than lung cancer within the last 5 years.
• Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids
• Severe medical problems other than the diagnosis of SCLC that would limit the ability of the subject to follow study plan or that would expose the subject to extreme risk.
• Ongoing or planned chemotherapy, immunotherapy, radiation treatment, or other experimental drug therapy for the treatment of SCLC.
• Use of investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication
• Women who are pregnant or lactating.
• Women who can become pregnant who refuse to practice an adequate form of birth control.
• Subjects with history of allergic reaction to chemicals related to HYCAMTIN and PARAPLATIN.
• Subjects with pre-existing heart disease, such as congestive heart failure, irregular heartbeats that require treatment, and heart attack within the last 3-months.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Tucson, Arizona, 85712, United States

Location

GSK Investigational Site

Concord, California, 94520, United States

Location

GSK Investigational Site

Sacramento, California, 95819, United States

Location

GSK Investigational Site

Boca Raton, Florida, 33486, United States

Location

GSK Investigational Site

Hollywood, Florida, 33021, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612, United States

Location

GSK Investigational Site

Munster, Indiana, 46321, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70006, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

Location

GSK Investigational Site

The Bronx, New York, 10467, United States

Location

GSK Investigational Site

Amarillo, Texas, 79106, United States

Location

GSK Investigational Site

Richmond, Virginia, 23230, United States

Location

GSK Investigational Site

Poznan, Poland

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Lung Neoplasms

Interventions

Topotecan; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2006
• First Posted: April 20, 2006
• Study Start: June 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 7, 2015
• Results First Posted: September 29, 2009

Record last verified: 2015-04

Locations

US (12); PL (1)