Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

NCT01302808 | Completed Phase 1 Results DMC

• 3 other identifiers: STU 012011-004CDR0000653093NCI-2011-01035
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Romidepsin and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of romidepsin when given together with erlotinib hydrochloride and to see how well they work in treating patients with stage III or stage IV non-small cell lung cancer.

Conditions

Lung Cancer; Metastatic Cancer

Keywords

recurrent non-small cell lung cancer; stage III B non-small cell lung cancer; stage IV non-small cell lung cancer; malignant pleural effusion; adenocarcinoma of the lung; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer; large cell lung cancer; squamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Limiting Toxicities and Maximum Tolerated Dose (MTD)

  Dose limiting toxicities per Protocol definition using (CTCAE), Version 3.0

  12 months

Secondary Outcomes (1)

• Area Under the Concentration-time Curve (AUC0 t) of Romidepsin in Combination With Erlotinib

  0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Days 1 and 8

Study Arms (4)

Cohort 1 (Erlotinib plus Romidepsin (8 mg/m^2))

EXPERIMENTAL

Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.

Combination Product: Erlotinib plus Romidepsin (8 mg/m^2)

Cohort 2 (Erlotinib plus Romidepsin (10 mg/m^2))

EXPERIMENTAL

Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.

Combination Product: Erlotinib plus Romidepsin (10 mg/m^2)

Cohort 3 (Erlotinib plus Romidepsin (10 mg/m^2)) + Antiemetic prophylaxis

EXPERIMENTAL

Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.

Combination Product: Erlotinib plus Romidepsin (10 mg/m^2) + Antiemetic prophylaxis

Cohort 4 (Erlotinib plus Romidepsin (8 mg/m^2)) + Antiemetic prophylaxis

EXPERIMENTAL

Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.

Combination Product: (Erlotinib plus Romidepsin (8mg/m^2)) + Antiemetic prophylaxis

Interventions

Erlotinib plus Romidepsin (8 mg/m^2) COMBINATION_PRODUCT

Also known as: Istodax®

Cohort 1 (Erlotinib plus Romidepsin (8 mg/m^2))

Erlotinib plus Romidepsin (10 mg/m^2) COMBINATION_PRODUCT

Also known as: Istodax®

Cohort 2 (Erlotinib plus Romidepsin (10 mg/m^2))

Erlotinib plus Romidepsin (10 mg/m^2) + Antiemetic prophylaxis COMBINATION_PRODUCT

Cohort 3 (Erlotinib plus Romidepsin (10 mg/m^2)) + Antiemetic prophylaxis

(Erlotinib plus Romidepsin (8mg/m^2)) + Antiemetic prophylaxis COMBINATION_PRODUCT

Cohort 4 (Erlotinib plus Romidepsin (8 mg/m^2)) + Antiemetic prophylaxis

Eligibility Criteria

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

You may qualify if:

• Negative urine or serum pregnancy test on females of childbearing potential;
• All women of childbearing potential must use an effective barrier method of contraception (an intrauterine contraceptive device \[IUCD\] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male patients should use a barrier method of contraception during the treatment period and for at least 1 month thereafter. Hormonal methods of contraception such as the contraceptive pill or patch (particularly those containing ethinyl-estradiol) should be avoided due to a potential drug interaction (see Appendix D).
• Adequate bone marrow, liver, and renal function as evidenced by
• Hemoglobin ≥10 g/dL (transfusions and/or erythropoietin-stimulating agents are permitted)
• Absolute neutrophil count (ANC) ≥1.5 x 109 cells/L • Platelet count ≥100 x 109 cells/L
• Total bilirubin \<1.5 x upper limit of normal (ULN)
• (Aspartate amino transferase) AST/SGOT(serum glutamic-oxaloacetic transaminase) and (amino alanine transferase) ALT/SGPT (serum glutamic-pyruvic transaminase) \<2.0 x upper limit of normal (ULN) or \<3.0 x ULN in the presence of demonstrable liver metastases
• Serum creatinine \<2.0 x ULN
• Clinically stable brain metastases are permitted
• Phase I study:
• Prior erlotinib therapy is permitted (with a 3-week washout period)
• Patients may have received prior anti-cancer therapy (with a 3-week washout period) or, at the discretion of the investigator, may be treatment-naïve
• Phase II study:
• Patients must have received at least one and no more than two prior chemotherapy regimens for their advanced NSCLC
• Patients may not have received prior erlotinib

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Celgene: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Erlotinib Hydrochloride; romidepsin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pleural Neoplasms; Pleural Effusion; Pleural Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Only phase 1 data are reported here as the maximum tolerated dose of romidepsin in combination with standard erlotinib 150 mg orally daily administration was 8 mg/m2. Therefore, it did not proceed to phase 2 (14 mg/m2 )

Results Point of Contact

• Title: David Gerber, MD
• Organization: UT Southwestern Medical Center

david.gerber@utsouthwestern.edu

2146484180

Study Officials

• David E. Gerber, MD

  Simmons Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 19, 2011
• First Posted: February 24, 2011
• Study Start: September 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 20, 2021
• Results First Posted: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)