Patients With Stage IV or Recurrent Adenocarcinoma of the LungPhase 2NCT02303977
Phase II Study of Abraxane and Gemicitabine in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer Progressing After First-Line Platinum-Based Chemotherapy
A Phase 2 study testing Abraxane and Gemcitabine in people with Patients With Stage IV or Recurrent Adenocarcinoma of the Lung, run by Abramson Cancer Center at Penn Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Stage IV or Recurrent Adenocarcinoma of the Lung
- What is being tested?
- Abraxane and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 26 Jun 2015to 30 Apr 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
- Negative serum β-hCG pregnancy test at screening for patients of childbearing potential.
- Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)
Who cannot join
- 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
About this study
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.
- Being tested
- Abraxane, Gemcitabine
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbraxaneDrug
GemcitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Abraxane; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Averaging about 16 weeks.
Secondary outcomes (3)
Progression-free Survival
Measures the length of time from the first day of therapy until Progressive Disease, death from any cause, or last patient contact. Disease Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Averaging about 16 weeks
Overall Survival
Length of time from the first day of therapy to death from any cause or last patient contact
Measured: Averaging about 47 weeks
Disease Control Rate
The percentage of patients with a Partial Response, a Complete Response, or Stable Disease during the study. 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.
Measured: The duration of study treatment, averaging about 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study start26 Jun 2015
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Stage IV or Recurrent Adenocarcinoma of the LungStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Ciunci, MD, Principal investigator, Abramson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303977
- Sponsor's protocol ID
- UPCC 21514
- Status last verified
- Sep 2021
- First submitted
- 26 Nov 2014
- Last updated
- 29 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 35393247
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Abraxane and Gemicitabine in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer Progressing After First-Line Platinum-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT02303977
- Acronym / sponsor ID
- UPCC 21514
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 26 Jun 2015 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Posted 29 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + Paciltaxel | Experimental | Drug: Abraxane, Drug: GemcitabineAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abraxane | Drug | Gemcitabine + Paciltaxel |
| Gemcitabine | Drug | Gemcitabine + Paciltaxel |
Primary outcome
Overall Response Rate
Time frame: Averaging about 16 weeks.
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.
3 secondary outcomes
Progression-free Survival
Time frame: Averaging about 16 weeks
Overall Survival
Time frame: Averaging about 47 weeks
Disease Control Rate
Time frame: The duration of study treatment, averaging about 16 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35393247Ciunci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Ciunci, MD principal investigator
Abramson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abraxane and Gemcitabine in people with Patients With Stage IV or Recurrent Adenocarcinoma of the Lung, run by Abramson Cancer Center at Penn Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Averaging about 16 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02303977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.