Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase I Study of Tetrathiomolybdate (TM) in Combination With Carboplatin and Pemetrexed in Chemo-Naive Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer
Verified date | July 2019 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of this study is to determine recommended phase II dose and safety of tetrathiomolybdate (TM) in combination with carboplatin and pemetrexed in chemo-naive metastatic or recurrent non-squamous non-small cell lung cancer.
Status | Completed |
Enrollment | 26 |
Est. completion date | January 11, 2019 |
Est. primary completion date | January 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: >18 years old Performance status 0-1 Newly diagnosed stage IV non-squamous non-small cell lung cancer or recurrent disease after prior surgery and/or irradiation Patients must not have received prior chemotherapy for any stage non small cell lung cancer Brain metastases allowed provided they have been controlled for = 2 weeks after completion of treatment and remain asymptomatic while off corticosteroids for at least 1 day Patient or primary care taker must be informed of and understand the investigational nature of this study and must sign and give written approved informed consent in accordance with institutional guidelines. If patient is of childbearing potential, she or he must agree to practice an effective method of birth control prior to study entry, for the duration of study participation, and for 30 days after the last study dose. Patient has adequate organ functions: serum bilirubin = 2.0 mg/dL; alanine aminotransferase (ALT) = 3 x upper limit of normal (ULN), or ALT = 5 x ULN if the patient has hepatic metastasis; serum creatinine = 1.5 mg/dL or a calculated creatinine clearance of at least 60 mL/min. Patient has adequate bone marrow reserve: absolute neutrophil count = 1,500, platelet count = 100,000, and hemoglobin = 9.0. Exclusion Criteria: Patient receiving any concurrent chemotherapy Patients who received platinum-based chemotherapy for any purpose Patients who had gastric bypass surgery Patients taking copper supplementation for medical reasons Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk Patients with active and uncontrolled infection Patients with concomitant active malignancy requiring treatment with cytotoxic chemotherapy or radiation therapy (ongoing hormonal therapy for treatment of malignancy would not exclude patients from this trial) Known anaphylactic or severe hypersensitivity to study drugs or their analogs. Patient has failed to recover from any prior surgery within 4 weeks of study entry. Patient has clinical evidence of copper deficiency (i.e. ceruloplasmin level was less than 15 mg/dL or free serum copper level less than 2.2 g/dL). Patients with tumors that are epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma receptor tyrosine kinase (ALK) positive. If biopsy specimen is insufficient or inadequate for EGFR and/or ALK testing, subjects are eligible for the study. Patients who are pregnant or lactating. |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with Adverse Events as a Measure of Safety and Tolerability | Determine phase II dose and safety of TM in combination with carboplatin and pemetrexed in chemo-naive metastatic or recurrent non-squamous non-small cell lung cancer. | 3 years | |
Secondary | Percentage of participants with Complete Response or Partial Response | Determine efficacy of carboplatin and pemetrexed doublet in combination with TM in chemo-naive metastatic or recurrent non-small cell lung cancer. | 3 years | |
Secondary | Time from date of enrollment to disease progression or death | 3 years | ||
Secondary | Expression of copper transporter by immunohistochemistry | Determine if pretreatment expression of copper transporter by immunohistochemistry predicts clinical outcome following platinum-based chemotherapy in combination with TM | 3 years | |
Secondary | Platinum sensitivity and copper status | Determine if ceruloplasmin level (a surrogate marker for copper status) is associated with platinum sensitivity | 3 years | |
Secondary | Platinum induced toxicity and copper status | Determine if ceruloplasmin level is associated with platinum-induced toxicity. | 3 years | |
Secondary | Impact on blood mineral levels. | To determine if Tetrathiomolybdate affects serum copper, iron, total iron binding capacity, ferritin or zinc levels when combined with platinum-based chemotherapy. | 3 years |
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