Phase II Study of Abraxane and Gemicitabine in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer Progressing After First-Line Platinum-Based Chemotherapy

NCT02303977 | Completed Phase 2 Results DMC

• 1 other identifier: UPCC 21514
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of this study is to see how well the combination of Abraxane and gemcitabine works in people with advanced adenocarcinoma NSCLC who have already had treatment for their disease. Gemcitabine and Abraxane are FDA approved chemotherapies; however, the FDA has not approved this combination in the treatment of this specific type of cancer. Patients may continue to receive the study drugs until their disease gets worse or they have unacceptable side effects.

Conditions

Patients With Stage IV or Recurrent Adenocarcinoma of the Lung

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  The percentage of patients with a Partial Response or Complete Response recorded from the start of the treatment until disease progression/recurrence by RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameter of target lesions; Overall Response (OR) = CR + PR.

  Averaging about 16 weeks.

Secondary Outcomes (3)

• Progression-free Survival

  Averaging about 16 weeks

• Overall Survival

  Averaging about 47 weeks

• Disease Control Rate

  The duration of study treatment, averaging about 16 weeks.

Study Arms (1)

Gemcitabine + Paciltaxel

EXPERIMENTAL

All patients were treated intravenously with albumin-bound paclitaxel at 100 mg/m2 plus gemcitabine at 1000 mg/m2 on days 1 and 8 of each three-week cycle.

Drug: Abraxane; Drug: Gemcitabine

Interventions

Abraxane DRUG

Gemcitabine + Paciltaxel

Gemcitabine DRUG

Gemcitabine + Paciltaxel

Eligibility Criteria

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

You may qualify if:

• Histologic or cytologic diagnosis of adenocarcinoma non-small cell lung cancer
• Stage IV non-small cell lung cancer or recurrent disease which cannot be approached with curative intent.
• First-line treatment with a standard platinum doublet chemotherapy regimen (carboplatin or cisplatin at standard dosing plus one of the following drugs at standard dosing: paclitaxel, docetaxel, vinblastine, vinorelbine, pemetrexed, or etoposide). Patients who received platinum-based chemotherapy for localized lung cancer (either adjuvant chemotherapy following surgery or chemotherapy given in conjunction with definitive radiation) are eligible if their cancer has recurred within 6 months of platinum-based chemotherapy.
• Must have recovered from toxic effects of prior chemotherapy
• ECOG performance status of 0-1
• Life expectancy of at least 12 weeks
• Age 18 or greater
• Must have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded as \> 20 mm with conventional techniques or \> 10 mm with spiral CT scanning).
• Patients with prior malignancies are allowed, provided they have been treated with curative intent and have no evidence of active disease.
• Patients must be capable of giving informed consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
• Bilirubin \< 1.5 mg/dL
• Patients must have adequate liver function: AST and ALT \< 2.5 X upper limit of normal, alkaline phosphatase \< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
• Patients must have adequate bone marrow function: Platelets \>100,000 cells/mm3, Hemoglobin \> 9.0g/dL and ANC \> 1,500 cells/mm3
• Patients must have adequate renal function: creatinine \<1.5 mg/dL
• Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment

You may not qualify if:

• Patients with EGFR or EML4-ALK mutations
• ECOG performance status \>1
• Patients previously treated with gemcitabine or Abraxane
• Uncontrolled intercurrent illness including, but not limited to: uncontrolled ongoing infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Known HIV or Hepatitis C
• Untreated central nervous system metastases. Patients are eligible if they are clinically stable, off all steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, stereotactic radio surgery) ending at least 2 weeks prior to enrollment, or after surgical resection performed at least 2 weeks prior to enrollment.
• Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent
• Pregnant or breast-feeding patients, as chemotherapy is thought to present substantial risk to the fetus/infant. Men and women of reproductive potential may not participate in this study unless they have agreed to use an effective contraceptive method while in this study. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients must agree to continue contraception for 3 months from the date of the last study drug administration

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Related Publications (1)

• Ciunci CA, Reibel JB, Evans TL, Mick R, Bauml JM, Aggarwal C, Marmarelis ME, Singh AP, D'Avella C, Cohen RB, Langer CJ. Phase II Trial of Combination Nab-paclitaxel and Gemcitabine in Non-squamous Non-small Cell Lung Cancer After Progression on Platinum and Pemetrexed. Clin Lung Cancer. 2022 Jun;23(4):e310-e316. doi: 10.1016/j.cllc.2022.02.004. Epub 2022 Mar 14.

  PMID: 35393247 DERIVED

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Christine Ciunci
• Organization: Abramson Cancer Center, Penn Presbyterian Medical Center

christine.ciunci@pennmedicine.upenn.edu

215-662-9801

Study Officials

• Christine Ciunci, MD

  Abramson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a prospective, single-arm, non-randomized, phase II trial designed to evaluate the efficacy of combination gemcitabine and albumin-bound paclitaxel for advanced adenocarcinoma non-small cell lung cancer progressing after first-line platinum-based chemotherapy.

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 1, 2014
• Study Start: June 26, 2015
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: September 29, 2021
• Results First Posted: September 29, 2021

Record last verified: 2021-09