Standard Chemotherapy With Blueberry Powder in Non-Small Cell Lung Cancer

NCT01426620 | Terminated Phase 2 DMC

• 1 other identifier: BCC-LUN-BIT-2
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial will evaluate phyto-therapy's, in the form of blueberry powder, synergistic effect on second-line therapy for non-small cell lung cancer (NSCLC). The proposition is that the addition of blueberry polyphenolics to routine docetaxel therapy will have a significant, positive effect in the response rate and overall survival.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; blueberry; salvage therapy; docetaxel; non-small cell lung cancer; second-line; polyphenol

Outcome Measures

Primary Outcomes (2)

• Proportion of patients successfully completing the entire treatment plan

  Completion of treatment plan by 10 patients. Feasibility and toxicity for the study will be evaluated in Part 1 of the study based on 10 patients completing the treatment plan (20 if 2 of the initial 10 patients develop toxicities).

  2 years after study enrollment

• Clinical Response Rate

  Clinical response (complete, partial and sustained) rates will be evaluated using Response Evaluation Criteria in Solid Tumor (RECIST) Guidelines (version 1.1)

  16 months after last treatment

Secondary Outcomes (6)

• Cumulative number of grade 3 or 4 toxic events

  2 years after study enrollment

• Progression-free survival (PFS) time

  16 months after last treatment

• Overall Survival (OS)

  2 years after time of enrollment of last participant

• Change in biomarker levels, measured by blood tests taken throughout the study

  2 years after study enrollment

• Quality of Life FACT-L measurement

  2 years after study enrollment

Study Arms (1)

Blueberry powder

EXPERIMENTAL

This is a two-part open-label clinical trial of blueberry powder administered to patients with stage IV NSCLC in combination with docetaxel as a second line treatment. Patients will initially be enrolled in part 1 of the study, which is the feasibility/toxicity evaluation section of the study. Once the part I enrollment is completed, the patients will be enrolled in part 2 of the study.

Dietary Supplement: Blueberry powder

Interventions

Blueberry powder DIETARY_SUPPLEMENT

The intervention consists of 2-3 packages (15 grams per package) of lyophilized blueberry powder, taken daily after mixing with natural yogurt, milk, water, or juice in combination with set dosage of docetaxel (35 milligrams per meter squared) administered intravenously every week for 4 cycles, 21-day cycles.

Blueberry powder

Eligibility Criteria

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

You may qualify if:

• Provide written informed consent prior to screening
• Male or female patients, age ≥ 18 years
• Histologically or cytologically confirmed diagnosis of NSCLC
• Stage IV disease (including patients with pleural effusion previously classified as Stage IIIB)
• All of the following if patient has had prior radiation therapy:
• lesion(s) used for determination of response were not previously irradiated or have increased in size since the completion of radiotherapy
• the patient has recovered from any acute effects of the radiotherapy
• radiotherapy was completed at least 4 weeks prior to screening
• Part 1: Have at least non-measurable evaluable disease (e.g., lesions which are smaller than the minimum size required for measurability; other non-measurable lesions such as bone metastases, malignant pleural effusion)
• Part 2: Have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as \> 10 millimeters (mm) on cross-sectional imaging (where the CT slice thickness is no greater than 5 mm) or at least 20 mm by standard techniques; positron emissions tomography \[PET\] and ultrasound are not permitted methods for tumor measurements under this protocol.
• Performance status of 0 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
• Have an estimated life expectancy of at least 12 weeks
• Adequate organ function within 14 days prior to first berry powder dose or docetaxel whichever occurs first, including the following - absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L), patients may receive packed red blood cells (RBC) transfusion to achieve this level at the discretion of the investigator, total bilirubin \< 1.5 x upper limit of normal (ULN) unless elevated secondary to conditions such as Gilbert's Disease, aspartate aminotransferase (AST) \< 3 x ULN (\< 5 x ULN in the presence of hepatic metastases), alanine aminotransferase (ALT) \< 3 x ULN (\< 5 x ULN in the presence of hepatic metastases), alkaline phosphatase \< 3.0 x ULN, calculated creatinine clearance ≥ 60 mL/min per Cockcroft and Gault formula
• Satisfy one of the following:
• Females: non-pregnant and non-lactating; surgically sterile, post-menopausal, or patient/partner compliant with a reliable contraceptive regimen, as determined by the Investigator, for 4 weeks prior to screening. Patients of reproductive potential must test negative for pregnancy at screening and must agree to use a reliable method of birth control during the study period

You may not qualify if:

• Part 1: More than one prior chemotherapy (single biological therapy, i.e., Erlotinib not included) regimens (approved or experimental) for NSCLC, not counting adjuvant and neoadjuvant treatment. A regimen is defined as two or more consecutive cycles of treatment. Part 2: Any prior chemotherapy or biological therapy (approved or experimental) for NSCLC including adjuvant and neoadjuvant treatments
• Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before screening or 5 half-lives of study agent, whichever is longer
• Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Brain imaging is required for symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients
• Patients with known pericardial effusion
• Patients with active infection or serious concomitant systemic disorder (for example, heart failure) incompatible with the study (at the discretion of the Investigator)
• Presence or history of malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer. In the case of other malignancies, patients may be considered for participation if the prior malignancies were diagnosed and definitively treated at least two years previously with no subsequent evidence of recurrence.
• Presence of an underlying disease state associated with active bleeding
• Concurrent treatment with other anticancer drugs
• Pre-existing peripheral neuropathy ≥ Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) Grade 2
• Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device
• Patients with any other medical conditions that in the opinion of the Investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study
• Allergy to berries

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Goetz H Kloecker, MD

  James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2011
• First Posted: August 31, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

US (1)