Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer

NCT02769832 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 201512799
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to see if Abraxane and Gemcitabine given together will be effective in treating small cell cancer that has progressed after one line of treatment.

Conditions

Small Cell Lung Cancer (SCLC)

Keywords

Abraxane; Albumin-bound Paclitaxel; SCLC; Gemzar

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall response rate is defined as the percentage of patients with a confirmed complete or partial response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI/CT scan: Complete response (CR) is the disappearance of all target lesions. Partial Response (PR), is at least a ≥ 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum of the longest diameter (LD). Progression of disease (PD) is at least a ≥ 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and as defined by RECIST v1.1 guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.

  Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)

Secondary Outcomes (3)

• Progression-Free Survival

  Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)

• Time to Progression

  Patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)

• Overall Survival

  Patients will be evaluated every 3 months until death or study completion (up to 3 years)

Study Arms (1)

Nab-Paclitaxel with Gemcitabine

EXPERIMENTAL

Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle

Drug: Nab-paclitaxel; Drug: Gemcitabine

Interventions

Nab-paclitaxel DRUG

Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle

Also known as: albumin-bound paclitaxel; paclitaxel protein-bound particles for injectable suspension (albumin-bound); Nab-paclitaxel Brand name: Abraxane ®

Nab-Paclitaxel with Gemcitabine

Gemcitabine DRUG

Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle

Also known as: Generic name: gemcitabine; Brand name: Gemzar ®

Nab-Paclitaxel with Gemcitabine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old, both male and female
• Histologically or cytologically confirmed SCLC SCLC or small cell cancer from other organs or poorly differentiated neuroendocrine tumors that are treated like small cell cancer. This study is for patients with metastatic or recurrent disease.
• ECOG performance status 0-2
• Patients must have at least one measurable lesion as defined per RECIST 1.1
• Progression during or after prior first line chemotherapy. Prior maintenance therapy, targeted therapy and immunotherapy are allowed. Prior use of Rovalpituzumab or other ADC agent is allowed. Immunotherapy or targeted therapy if used as 2nd line therapy will not be considered as second line therapy as these are not true chemotherapeutic agents. Patients treated with definitive chemo-radiation will be eligible if they progressed within a year of definitive therapy (as definitive therapy will be considered 1st line therapy for these patients).
• Before study therapy, a minimum of 21 days must have elapsed since any prior chemotherapy and 2 weeks from the last dose of prior targeted or immunotherapy.
• Prior definitive XRT is allowed if it has been 2 weeks since the end of definitive XRT. For palliative XRT, protocol-specified treatment can begin at minimum 48 hours after completion of radiation. Lesions within the XRT field can only be used as target lesions if definite progression has been demonstrated since the completion of radiation.
• Adequate major organ function including the following:
• Hematologic function: Absolute neutrophil count (ANC) ≥ 1800 /mm3, platelet count ≥ 100,000/mm3, and Hgb ≥ 9.0 gm/dl.
• Hepatic function: bilirubin ≤ 1.5 x ULN, AST and ALT levels ≤ 2.5 x ULN. If liver metastases are present, then AST and ALT ≤ 5 x ULN.
• Renal function: serum creatinine ≤ 1.5 x ULN.
• Patients must be willing and able to sign informed consent for themselves
• If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 6 months after trial. If male, use of an approved contraceptive method during the study and 6 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study therapy.
• Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy \[the surgical removal of the uterus\] or bilateral oophorectomy \[the surgical removal of both ovaries\] or (2) has not been naturally postmenopausal for at least 24 consecutive months \[i.e., has had menses at any time during the preceding 24 consecutive months\]) must:
• Either commit to true abstinence\* from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP therapy (including dose interruptions), and while on study medication or for a longer period if required by local regulations following the last dose of IP; and

You may not qualify if:

• Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:
• Pregnant women
• Nursing women
• Men or women of childbearing potential, who are unwilling to employ adequate contraception as determined by treating physician, while on this study and for 6 months after the end of treatment with the study drugs.
• History of the following within the prior 6 months: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder
• Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
• History of other invasive malignancy that is currently active and/or has been treated within 12 months prior to enrollment (notable exceptions include: basal cell carcinoma, squamous cell carcinoma of the skin, localized prostate cancer, in situe carcinomas of the cervix and breast, and superficial bladder cancers \[non-muscle invasive\]).
• Psychiatric disorder which, per treating physician discretion, may preclude compliance
• Major surgery in the last two weeks of starting study therapy. This does not include procedures like biopsy (needle or excisional) or port placement as these are not considered as major surgery.
• Individuals with the presence of symptomatic CNS metastasis requiring radiation, surgery, or ongoing use of corticosteroids. Untreated or brain metastasis causing any symptoms. Treated brain metastasis must be stable for 4 weeks prior to first dose of study drug and not require steroids for at least 7 days prior to study treatment.
• Pre-existing peripheral neuropathy \> Grade 1 (using CTCAE v 4.3 criteria)
• Received any prior treatment with any taxane (docetaxel or paclitaxel) for small cell lung cancer.
• History of allergy or hypersensitivity to albumin-bound paclitaxel, or gemcitabine.

Sponsors & Collaborators

• Muhammad Furqan: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52317, United States

Location

Related Publications (1)

• Byrne MM, Sutamtewagul G, Zeitler W, Mott SL, Zamba GKD, Kojadinovic A, Zhang J, Abu-Hejleh T, Clamon G, Furqan M. Phase II study of nab-paclitaxel with gemcitabine for relapsed/refractory small cell lung cancer. Front Oncol. 2024 Jul 31;14:1303268. doi: 10.3389/fonc.2024.1303268. eCollection 2024.

  PMID: 39144826 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

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

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: Muhammad Furqan, MD
• Organization: University of Iowa, Holden Comprehensive Cancer Center

muhammad-furqan@uiowa.edu

319-356-1527

Study Officials

• Muhhamad Furqan, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor Hematology/Oncology

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: May 12, 2016
• Study Start: August 29, 2016
• Primary Completion: September 23, 2021
• Study Completion: July 7, 2022
• Last Updated: July 29, 2025
• Results First Posted: July 21, 2023

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)