Phase 3 Study of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin

Study Description

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Brief Summary:

Tavocept is an investigational drug that is being developed to see if it can increase the survival of patients who are being treated with chemotherapy as well as to see if it can prevent or reduce side effects of chemotherapy. This research study is aimed at trying to find out if people with advanced adenocarcinoma of the lung who are treated with a standard combination of chemotherapy drugs will live longer if they are also treated with an investigational drug called "Tavocept." Another objective of this research study is to find out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage, anemia, and nausea and vomiting that can occur with these drug combinations. The drug combinations that will be used in this research study will include either paclitaxel and cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to treat people with advanced NSCLC. Every patient on this research study will be treated with standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these will be recommended by your research study doctor), which will be given in combination with cisplatin.

Condition or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer	Drug: Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel; Drug: Placebo in combination with cisplatin and docetaxel or paclitaxel	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	540 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Randomized, Multicenter, Double-blind, Phase 3 Trial of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin
Study Start Date :	April 2010
Actual Primary Completion Date :	April 2013
Actual Study Completion Date :	June 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo in combination with cisplatin and either paclitaxel or docetaxel	Drug: Placebo in combination with cisplatin and docetaxel or paclitaxel; Paclitaxel 200 mg/m2 IV or Docetaxel 75mg/m2 IV every 3 weeks plus Cisplatin 80 mg/m2 IV every 3weeks plus Placebo IV every 3 weeks
Active Comparator: Tavocept (BNP7787); Tavocept (BNP7787) in combination with cisplatin and either docetaxel or paclitaxel	Drug: Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel; Paclitaxel 200 mg/m2 IV or Docetaxel 75mg/m2 IV every 3 weeks plus Cisplatin 80 mg/m2 IV every 3weeks plus Tavocept(BNP7787) 18.4gm/m2 IV every 3 weeks; Other Name: BNP7787

Outcome Measures

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Primary Outcome Measures :

1. Overall Survival [ Time Frame: throughout study ]

Secondary Outcome Measures :

1. Progression Free Survival [ Time Frame: Every 2 cycles during study treatment then every 6-8 weeks after going off study for up to 6 months, or until progression or initiation of further treatment ]
2. Incidence of 30% or greater decrease in the calculated creatinine clearance relatively to baseline [ Time Frame: throughout the study ]
3. Incidence of NCI-CTCAE grade 2,3, or 4 anemia [ Time Frame: throughout the study ]
4. Proportion of patients having no impact of chemotherapy-induced emesis on daily life [ Time Frame: throughout the study ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Confirmed histopathological diagnosis of inoperable advanced primary adenocarcinoma (including bronchioalveolar cell carcinoma) of the lung
• No prior systemic treatment for non-small cell lung cancer including chemotherapy, immunotherapy, hormonal therapy, targeted therapies or investigational drugs

Exclusion Criteria:

• Small cell, squamous cell, large cell or undifferentiated or any form of mixed (eg, small cell and adenocarcinoma or squamous and adenocarcinoma) histopathological or cytological diagnosis of primary lung cancer
• Adenocarcinoma arising from primary sites other than the lung
• Patients without documented Stage 4 disease (in accordance with AJCC TMM Staging System 7th edition)
• Patients with unstable CNS mets within 21 days before randomization

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 43 Study Locations

Sponsors and Collaborators

BioNumerik Pharmaceuticals, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00966914 History of Changes
Other Study ID Numbers:	DMS32212R
First Posted:	August 27, 2009
Last Update Posted:	September 21, 2017
Last Verified:	September 2017

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type	Paclitaxel; Docetaxel; Albumin-Bound Paclitaxel; Cisplatin; Mesna; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs