Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

All Drugs and Chemicals

Antineoplastic Agents

Hypoglycemic Agents

Antibodies

Antibodies, Monoclonal

Etoposide

Insulin

Insulin, Globin Zinc

Cisplatin

Etoposide phosphate

Immunoglobulins

Mitogens

Immunologic Factors

Enzyme Inhibitors

MK-0646, a monoclonial antibody in combination with etoposide and cisplatin.

MK-0646 should be given 1st followed within 30-60 minutes by cisplatin and then etoposide for cycles which include both MK-0646 and chemotherapy. Cycles are 21 days

anti-IGF-1R recombinant monoclonal antibody MK-0646

cisplatin

etoposide

Peter Ellis, MD

RATIONALE: Monoclonal antibodies, such as MK-0646, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I/II trial is studying the side effects and best dose of MK-0646 when given together with etoposide and cisplatin and to see how well it works in treating patients with extensive-stage small cell lung cancer.

OBJECTIVES:

* To determine the recommended phase II dose of MK-0646 in combination with a standard etoposide and cisplatin chemotherapy regimen in patients with extensive stage small cell lung cancer. (phase I)
* To assess the toxicity and tolerability of this regimen in these patients. (phases I and II)
* To evaluate the preliminary efficacy of this regimen in these patients. (phase I)
* To assess the efficacy of this regimen, in terms of objective response rate, as well as complete response rate in these patients. (phase II)
* To assess progression-free survival and overall survival of patients treated with this regimen. (phase II)
* To explore the predictive and prognostic impact of biomarkers in patients treated with this regimen. (phase II)

OUTLINE: This is a multicenter, phase I, dose-escalation study of MK-0646 followed by a phase II study.

Patients receive MK-0646 IV over 1 hour on days 1, 8, and 15 and cisplatin IV and etoposide IV once daily on days 1-3. Treatment repeats every 3 weeks for 4 to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients with complete response (CR) or partial response (PR) may continue MK-0646 in the absence of disease progression, with temporary discontinuation while undergoing prophylactic cranial irradiation or thoracic radiotherapy.

Blood samples are collected at baseline (pre-dose) and periodically for biomarker and pharmacogenetic correlative studies. Blood samples are analyzed for changes in expression of IGF biomarkers (e.g., IGF-1, IGF-2 and IGF-PB), haplotype tagging analysis of the IGF-1R, and evaluation of the immunoglobulin G fragment C receptor polymorphisms.

After completion of study therapy, patients are followed at 4 weeks. Patients with responding disease (i.e., CR, PR, or stable disease) are followed every 3 months until relapse or progression.

MK-0646, Etoposide, and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

A Phase I-II Trial of MK-0646, a Monoclonal Antibody Against Insulin-Like Growth Factor-1 Receptor, in Combination With Etoposide and Cisplatin in Extensive Stage Small Cell Lung Cancer

Evaluate safety, tolerability in combination with standard chemotherapy.

Look at toxicity and tolerability of MK0646 in combination with standard therapy.

Determine objective response rate including complete response rate, progression free survival and overall survival.

Blood samples will be collected and analyzed for occurrence of human-anti-humanized antibody response to MK0646 as well as IGF-1R analysis.

Merck Frosst Canada Ltd.

NCIC Clinical Trials Group

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Adenocarcinoma

Recurrence

Adenocarcinoma of Lung

Adenocarcinoma, Bronchiolo-Alveolar

Lung Adenocarcinoma

Vinorelbine

Topotecan

Topoisomerase I Inhibitors

Tubulin Modulators

Antimitotic Agents

topotecan hydrochloride

vinorelbine tartrate

Andrew S. Kraft, MD

Gustavo Leone

RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of topotecan when combined with vinorelbine ditartrate in patients with recurrent lung cancer.

Secondary

* Assess the response and stable disease rates and the time to disease progression among treated patients.

OUTLINE: This is a dose-escalation study of topotecan.

Patents receive vinorelbine ditartrate IV over 8-10 minutes and topotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which ≥ 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer

Medical University of South Carolina

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MK-0646, Etoposide, and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer	NCT00869752	Lung Cancer	anti-IGF-1R rec... cisplatin etoposide	18 Years -	Canadian Cancer Trials Group
Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer	NCT00287963	Lung Cancer	topotecan hydro... vinorelbine tar...	18 Years - 120 Years	Medical University of South Carolina
Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer	NCT00287963	Lung Cancer	topotecan hydro... vinorelbine tar...	18 Years - 120 Years	Medical University of South Carolina

Spots Global Cancer Trial Database for combined type small cell lung cancer