Phase I/II Trial of RAD001 Plus Docetaxel in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer

NCT00406276 | Terminated Phase 1 Results DMC

• 1 other identifier: 1342-2004
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-arm, Phase I/II trial to determine the safety of RAD001 in combination with docetaxel and compare the efficacy of RAD001 plus docetaxel versus published Phase II and III reports of docetaxel alone in patients with recurrent NSCLC.

Conditions

Lung Cancer

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Subjects Showing Partial Response and Stable Disease With the Combination of RAD001 and Docetaxel.

  Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as reference the smallest sum Longest diameter(LD) since treatment started.

  6 weeks

• Time to Progression:Time Period (in Months) From Study Entry Until Disease Progression, Death, or Last Date of Contact.

  Period from study entry until disease progression, death, or last date of contact. Progressive Disease: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

  6 months

Study Arms (1)

RAD001+Docetaxel

EXPERIMENTAL

RAD001 in combination with Docetaxel.

Drug: RAD001; Drug: Docetaxel

Interventions

RAD001 DRUG

RAD001 will be given at a dose of 5mg/day in combination with docetaxel

RAD001+Docetaxel

Docetaxel DRUG

In combination with RAD001

RAD001+Docetaxel

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically confirmed non-small cell lung cancer (NSCLC) which is accessible to biopsy.
• Patient must have ECOG Performance Status of 0, 1, or 2.
• Life expectancy greater than 12 weeks.
• Patient must have adequate bone marrow, renal and hepatic function as defined in the protocol.
• Completed all prior therapy at least 3 weeks prior to registration and be adequately recovered from that therapy.
• Must be at least 18 years of age.
• Meet pre-entry requirements as specified in Section 7.0.
• Female patients of child-bearing potential must have a negative serum pregnancy test prior to study entry.
• Patients of child-bearing potential must agree to use an effective form of contraception while on study and for 3 months following completion of study treatment.
• Patient must not have more than one prior chemotherapy regimen.
• Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

You may not qualify if:

• Chronic treatment with systemic steroids or other immunosuppressive agents.
• Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
• A known history of HIV seropositivity.
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
• Patients with an active, bleeding diathesis or an oral anti-vitamin K medication (except low dose coumadin).
• Known hypersensitivity to everolimus, sirolimus, or any of its excipients.
• Patient is pregnant or breast-feeding.
• Patient has intercurrent illness including, but not limited to: ongoing active or severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, myocardial infarction within 6 months, uncontrolled diabetes mellitus, chronic liver or renal disease, active upper GI tract ulceration or psychiatric illness/social situations that would limit compliance with study requirements.
• Patient is unable to swallow RAD001.
• History of other invasive malignancies, with the exception of non-melanoma skin cancer, if there is any evidence of the malignancy being present within the past 5 years.
• History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. Symptoms may include any reaction such as bronchospasm, generalized urticaria, systolic BP ≤ 80mm Hg, and angioedema.
• Patient has received treatment with an investigational agent within 4 weeks of registration.
• Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Everolimus; Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr.Suresh Ramalingam, MD
• Organization: Emory University

ssramal@emory.edu

404-778-5378

Study Officials

• Suresh Ramalingam, MD

  Emory University Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: December 4, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2013
• Last Updated: August 23, 2013
• Results First Posted: May 28, 2012

Record last verified: 2013-08

Locations

US (1)