Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Recurrence

Small Cell Lung Carcinoma

Lung Neoplasms

Mediastinal Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Mediastinal Diseases

Thoracic Diseases

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Topotecan

Tubulin Modulators

Antimitotic Agents

Topoisomerase I Inhibitors

Enzyme Inhibitors

Weekly intravenous topotecan with intravenous docetaxel

Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days

Intravenous Topotecan

Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 \& 8 of a 21 day cycle

Intravenous Docetaxel

Raza Khan, MD

The purposes of this study are:

* To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
* To determine the feasibility and toxicity of the combination of topotecan and docetaxel.

The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.

Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.

Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer

To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel

GlaxoSmithKline

Aultman Health Foundation

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Genital Neoplasms, Female

Testicular Neoplasms

Genital Neoplasms, Male

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Genital Diseases, Male

Male Urogenital Diseases

Testicular Diseases

Ovarian Cancer

Germ Cells Tumors

Nonseminomatous Germ Cell Tumor

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.

Nasser Hanna, M.D.

This is an open label, multi-institutional, single arm phase II trial of pembrolizumab in patients with incurable platinum refractory germ cell tumors. No randomization or blinding is involved.

OUTLINE: This is a multi-center study.

Eligible subjects must have received initial cisplatin-based combination therapy, such as bleomycin-etoposide-cisplatin (BEP), cisplatin-etoposide (EP), etoposide-ifosfamide-cisplatin (VIP), or similar regimens AND demonstrated progression following the administration of at least one 'salvage' regimen for advanced germ cell neoplasm, such as high dose chemotherapy, paclitaxel-ifosfamide-cisplatin (TIP), or vinblastine-ifosfamide-cisplatin (VeIP).

INVESTIGATIONAL TREATMENT:

Pembrolizumab 200mg IV every 3 weeks until progression or toxicity. Treatment will continue for up to 52 weeks in the absence of prohibitive toxicities or disease progression.

The following screening labs to demonstrate adequate organ function must be performed within 10 days of treatment initiation:

Hematological:

* Absolute neutrophil count (ANC) ≥1,500 /mcL
* Platelets ≥100,000 / mcL
* Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or hematopoietin (EPO) dependency (within 7 days of assessment)

Renal:

* Serum creatinine ≤1.5 X upper limit of normal (ULN) OR
* Measured or calculated creatinine clearance ≥60 mL/min for subject with creatinine levels \>1.5 X institutional ULN
* Glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (CrCl)

Hepatic:

* Serum total bilirubin ≤ 1.5 X ULN OR
* Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN
* AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
* Albumin \>2.5 mg/dL

Coagulation:

* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
* Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors

A Phase II Single-Arm Multi-Center Trial Evaluating the Efficacy of Pembrolizumab in the Treatment of Subjects With Incurable Platinum-Refractory Germ Cell Tumors: Hoosier Cancer Research Network GU14-206

CBR of single agent pembrolizumab in subjects with refractory germ cell tumors (GCTs), determined by sum of complete responses, partial responses, and stable disease for at least 3 months using Immune Related Response Criteria (irRC).

Complete Response(irPR): Disappearance of all lesions in two consecutive observations not less than 4 wk apart.

Partial Response (irPR): decrease in tumor burden ≥50 %relative to baseline confirmed by a consecutive assessment at least 4 wk after first documentation.

Stable Disease (irSD): not meeting criteria for irCR or irPR, in absence of irPD.

Toxicity and tolerability of pembrolizumab in subjects with refractory GCTs. All grade 3 and higher adverse events are reported.

ORR of single agent pembrolizumab in subjects with refractory GCTs, determined by sum of complete responses and partial responses for at least 3 months using RECIST 1.1 criteria

Hoosier Cancer Research Network

Merck Sharp & Dohme LLC

Sponsor-Investigator

Pembrolizumab

Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.

Experimental Arm

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Location Of Primary Tumor

Tumor Histology

Predominant Histology

Number of Previous Chemotherapy Regimens

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead

ECOG Performance Status

Retroperitoneum

Pulmonary

Non Pulmonary Visceral Metastasis

The overall count of metastatic location(s). Subjects may have metastasis at multiple locations.

Metastatic Site(s)

This study was terminated early due to not meeting the primary efficacy endpoint at a pre-planned interim analysis.

Clinical Data Coordinator

Clinical Benefit Rate (CBR)

Skin and subcutaneous tissue disorders

Noncardiac chest pain

Anemia

Sciatic pain

Number of Participants With Adverse Events as a Measure of Safety and Tolerability Using Common Terminology Criteria for Adverse Events (CTCAE) V4.

Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.

Disease Assessment for Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Criteria

Disease Assessment for Duration of Disease Response

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer	NCT00315211	Mediastinal Neo...	Intravenous Top... Intravenous Doc...	18 Years -	Aultman Health Foundation
Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors	NCT02499952	Germ Cell Neopl... Testicular Neop... Non Seminomatou... Mediastinal Neo... Genital Neoplas... Genital Neoplas... Ovarian Neoplas...	Pembrolizumab	18 Years -	Hoosier Cancer Research Network

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