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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer

  • Clinicaltrials.gov identifier

    NCT02769832

  • Recruitment Status

    Active, not recruiting

  • First Posted

    May 12, 2016

  • Last update posted

    June 9, 2021

Study Description

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.

  • Condition or Disease:Small Cell Lung Cancer (SCLC)
  • Intervention/Treatment: Drug: Nab-paclitaxel
    Drug: Gemcitabine
  • Phase: Phase 2

Detailed Description

This study is designed as a second-line therapy for patients with histologically or cytologically confirmed small cell lung cancer 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. Eligible patients will receive Nab-Paclitaxel (Abraxane), 100 mg/m2, IV over 30 minutes on Days 1 and 8 of a 21-day cycle followed by Gemcitabine, 1000 mg/m2, IV over 30 minutes on Days 1 and 8 of a 21-day cycle. Participants can continue receiving Nab-Paclitaxel and Gemcitabine until disease progression, unacceptable toxicity or withdrawal from the study. Tumor measurements will be done every 2 cycles.

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 32 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Phase II Study of Nab-Paclitaxel With Gemcitabine for Relapsed Small Cell Cancer or Those With Progression on First Line Therapy
  • Actual Study Start Date: August 2016
  • Estimated Primary Completion Date: May 2025
  • Estimated Study Completion Date: May 2025

Arms and interventions

Arm Intervention/treatment
Experimental: Nab-Paclitaxel with Gemcitabine
Nab-paclitaxel 100 mg/m2, day 1, 8 q 21 days; Gemcitabine 1000 mg/m2, day 1, 8 q 21 days
Drug: Nab-paclitaxel
Nab-paclitaxel 100 mg/m2, day 1, 8 q 21 days

Drug: Gemcitabine
Gemcitabine 1000 mg/m2, day 1, 8 q 21 days

Outcome Measures

  • Primary Outcome Measures: 1. Response Rate (change at evaluations) [ Time Frame: Change on two consecutive evaluations at least 8 weeks apart until study completion, up to 4 years. Patients will be evaluated every 2 months for 2 years; then every 6 months until study completion; up to 4 years. ]
    To evaluate the response rate per RECIST 1.1 of nab-paclitaxel plus gemcitabine (with clinically meaningful response rate defined as 35% of patients responding).
  • Secondary Outcome Measures: 1. To estimate the time to progression [ Time Frame: Patients will be evaluated every 2 months for 2 years; then every 6 months until disease progression or study completion; up to 4 years. ]
    To estimate the time to progression (defined as the first day of treatment to the date that disease progression is reported).
  • 2. To estimate the overall survival [ Time Frame: Patients will be evaluated every 2 months for 2 years; then every 6 months until death or study completion; up to 4 years. ]
    To estimate the overall survival (defined as the first day of treatment to the date of death due to any cause).
  • 3. To examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients. [ Time Frame: All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s) up to 4 weeks after the last date of any study therapy or through study completion, up to 4 years. ]
    To examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients. Patients will be evaluated at each scheduled visit for treatment related adverse events during the course of treatment and up until 4 weeks after last date of any study therapy.

Eligibility Criteria

  • Ages Eligible for Study: 18 to 99 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion criteria

1. Age ≥18 years old, both male and female

2. 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.

3. ECOG performance status 0-2

4. Patients must have at least one measurable lesion as defined per RECIST 1.1

5. 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).

6. 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.

7. 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.

8. 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.

9. Patients must be willing and able to sign informed consent for themselves

10. 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

Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing
pregnancy testing during the course of the study, as per clinical judgement of the
investigator, and after the end of study therapy. This applies even if the subject
practices true abstinence* from heterosexual contact.

11. Male subjects must practice true abstinence* or agree to use a condom during sexual
contact with a pregnant female or a female of childbearing potential while
participating in the study, during dose interruptions and for 6 months following IP
discontinuation, even if he has undergone a successful vasectomy.

- True abstinence is acceptable when this is in line with the preferred and usual
lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation,
symptothermal, post-ovulation methods) and withdrawal are not acceptable methods
of contraception].

Exclusion criteria

1. 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.

2. 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

3. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose
control may be jeopardized by complication of study therapy

4. 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]).

5. Psychiatric disorder which, per treating physician discretion, may preclude compliance

6. 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.

7. 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.

8. Pre-existing peripheral neuropathy > Grade 1 (using CTCAE v 4.3 criteria)

9. Received any prior treatment with any taxane (docetaxel or paclitaxel) for small cell
lung cancer.

10. History of allergy or hypersensitivity to albumin-bound paclitaxel, or gemcitabine.

Contacts and Locations

Contacts

Locations

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City

Sponsors and Collaborators

Muhammad Furqan

Celgene Corporation

Investigators

Principal Investigator: Muhhamad Furqan, MD University of Iowa

More Information

  • Responsible Party: Muhammad Furqan
  • ClinicalTrials.gov Identifier: NCT02769832 History of Changes
  • Other Study ID Numbers: 201512799
  • First Posted: May 12, 2016 Key Record Dates
  • Last Update Posted: June 9, 2021
  • Last Verified: June 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Muhammad Furqan: Abraxane
    Albumin-bound Paclitaxel
    SCLC
    Gemzar
  • Additional relevant MeSH terms: Small Cell Lung Carcinoma Carcinoma, Small Cell