Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection

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Brief Title

Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection

Official Title

A Phase 1 Study of Paclitaxel and Carboplatin in Solid Tumors (With Focus on Upper Aerodigestive Cancers) in Persons With HIV Infection

Brief Summary

      This phase I clinical trial is studying the side effects and the best dose of vorinostat when
      given together with paclitaxel and carboplatin in treating patients with metastatic or
      recurrent solid tumors and human immunodeficiency virus (HIV) infection. Vorinostat may stop
      the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used
      in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving
      vorinostat together with paclitaxel and carboplatin may kill more tumor cells.

      NOTE: An administrative decision was made by NCI to halt further study of vorinostat in this
      specific patient population as of February 1, 2013. No patients remain on vorinostat. Going
      forward this study will determine the safety and tolerability of the paclitaxel and
      carboplatin combination in this patient population.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the safety and tolerability of vorinostat in combination with paclitaxel and
      carboplatin in solid tumor patients with HIV infection.

      II. To determine the maximal tolerated dose (MTD) of the combination in this patient
      population.

      *NOTE: An administrative decision was made by Cancer Therapy Evaluation Program (CTEP) to
      halt further study of vorinostat in this specific patient population as of February 1, 2013,
      and no patients remain on vorinostat. The primary objective going forward will determine the
      safety and tolerability of the paclitaxel and carboplatin combination in this patient
      population.

      SECONDARY OBJECTIVES:

      I. To preliminarily assess response rates of the therapeutic combination in lung, head and
      neck, and esophageal cancers.

      II. To evaluate the pathological characteristics of non-acquired immunodeficiency syndrome
      (AIDS) defining cancers of the upper aerodigestive tract.

      III. To determine the presence and oncogenic activity of human papillomavirus (HPV) infection
      in tumor tissues and to correlate HPV infection with clinical outcomes.

      IV. To investigate possible pharmacokinetic interactions between paclitaxel and
      antiretroviral therapy in persons with HIV infection.

      OUTLINE: This is a multicenter, dose-escalation study of vorinostat followed by an expansion
      cohort study.

      Patients receive vorinostat orally (PO) once daily on days 1-5 and paclitaxel intravenously
      (IV) over 3 hours and carboplatin IV over 30 minutes on day 3. Treatment repeats every 21
      days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

      Some patients undergo blood sample collection at baseline and periodically during course 1
      for pharmacokinetic studies and HIV viral load analysis.

      Note: An administrative decision was made by CTEP to halt further study of vorinostat in this
      specific patient population as of February 1, 2013. No patients remain on vorinostat. The
      primary objective going forward will determine the safety and tolerability of the paclitaxel
      and carboplatin combination in this patient population, without vorinostat. The information
      pertaining to vorinostat is for historical purposes.

      After completion of study therapy, patients are followed up every 6 months for up to 3 years.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Incidence of adverse events during paclitaxel and carboplatin treatment according to dose-limiting toxicities (DLTs), graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)

Secondary Outcome

 Response rates in patients with lung, head and neck, and esophageal cancers assessed by Response Evaluation Criteria for Solid Tumors (RECIST) 1.1

Condition

HIV Infection

Intervention

vorinostat

Study Arms / Comparison Groups

 Treatment (carboplatin, paclitaxel)
Description:  Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Before February 1, 2013, patients also received vorinostat PO once daily on days 1-5 with paclitaxel and carboplatin.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

17

Start Date

November 2013

Completion Date

December 2017

Primary Completion Date

May 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have known HIV infection and histologically confirmed solid malignancy
             that is metastatic or unresectable and is therefore incurable; although the focus of
             this trial will be on upper aerodigestive cancers (non-small cell lung cancer, head
             and neck squamous cell carcinoma, and non-gastroesophageal junction esophageal
             cancer), patients with other incurable solid tumor with disease potentially sensitive
             to carboplatin and/or taxanes (including but not limited to salivary gland cancer,
             gastric cancer, breast cancer, ovarian cancer, or anal cancer, BUT excluding Kaposi
             sarcoma), will be eligible

          -  Up to 1 prior systemic therapy regimen will be permitted for palliative treatment of
             metastatic or unresectable relapsed disease; however, previous chemotherapy delivered
             with curative-intent (i.e., chemoradiotherapy or adjuvant [postoperative] chemotherapy
             at a time disease was considered potentially curable) will be permitted; prior taxane
             (including paclitaxel or docetaxel) and/or platinum exposure will be permitted;
             however, patients must not experience disease progression within 3 months of
             platinum-based therapy; at least 4 weeks must have elapsed since prior chemotherapy or
             radiation therapy, 6 weeks if the last regimen included carmustine (BCNU) or mitomycin
             C; toxicities from prior anticancer therapy must have recovered to =< Grade 1

          -  Serologic documentation of HIV infection at any time prior to study entry, as
             evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive Western
             Blot, or any other federally approved licensed HIV test; a positive HIV viral load
             prior to study entry will also be permitted

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)

          -  Documented life expectancy of greater than 12 weeks

          -  Leukocytes >= 3,000/mcL

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin within normal institutional limits

          -  Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase [SGPT]) =<
             2.5 X institutional upper limit of normal

          -  Creatinine within normal institutional limits OR creatinine clearance >= 50
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  Additionally, serum magnesium and potassium must be within institutional normal
             limits, and a CD4 count > 100/mcL will be required within 2 weeks of study
             participation

          -  Presence of at least one measureable tumor lesion is required

          -  Participating patients must receive medically appropriate care and treatment for HIV
             infection, including antiretroviral medications, when clinically indicated, and should
             be under the care of a physician experienced in HIV management; with the exception of
             treatment with zidovudine and stavudine, patients will be eligible regardless of
             antiretroviral regimen (no antiretroviral therapy, nonnucleoside reverse transcriptase
             inhibitors [NNRTI]-based therapy, or protease inhibitor based therapy), provided there
             is no intention to initiate therapy or the regimen has been stable for at least 4
             weeks with no intention to change the regimen within 8 weeks following study entry;
             the exact regimen used for HIV therapy will be captured on Case Report Forms; as
             study-specific (antiretroviral therapy-based) strata fill, however, only patients
             fitting the remaining open strata will be accrued

          -  Because histone deacetylase inhibitors as well as other therapeutic agents used in
             this trial are known to be teratogenic, women of child-bearing potential and men must
             agree to use adequate contraception (hormonal or barrier method of birth control;
             abstinence) prior to study entry, during the duration of study participation, and for
             at least 3 months following study completion; should a woman become pregnant or
             suspect she is pregnant while participating in this study, she should inform her
             treating physician immediately; women of child-bearing potential must have a negative
             pregnancy test within 7 days before initiation of study drug dosing; post menopausal
             women must be amenorrheic for at least 12 months to be considered of non-childbearing
             potential; (Note: A woman of childbearing potential is one who is biologically capable
             of becoming pregnant; this includes women who are using contraceptives or whose sexual
             partners are either sterile or using contraceptives)

          -  Ability to understand and the willingness to sign a written informed consent document;
             as the correlative studies are critical to the clinical and scientific value of the
             trial, CD4 count/HIV viral load determinations will be required, and participation in
             the tumor-based correlative studies will be strongly recommended; additionally,
             investigators MUST request sample donation to the AIDS Cancer Specimen Resource
             (ACSR); however, the patient may refuse sample donation; patients accrued to the
             expansion phase of the study will be required to undergo pharmacokinetic sampling

          -  Subjects must in the opinion of the Investigator be capable of complying with this
             protocol

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from adverse events (toxicities not improved to =< Grade 1) due to agents
             administered more than 4 weeks earlier; additionally, patients experiencing disease
             progression within 3 months of platinum-based therapy will be excluded from trial
             participation

          -  Due to availability of effective first- and second-line therapies (as well as
             disease-specific clinical trials), patients with diagnosis of active Kaposi sarcoma
             will be excluded from study participation; however, persons with other active
             malignancy with prior history of Kaposi sarcoma can be considered for participation at
             the discretion of the Study Chair

          -  Patients may not be receiving any other investigational agents

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to the study agents used in study (including hypersensitivity to
             paclitaxel, Cremophor, or platins)

          -  For subjects assigned to take vorinostat, inability to take oral medications;
             vorinostat capsules must be administered whole; note: this criterion does NOT apply to
             subjects treated on the Expansion Cohort (accruals post February 1, 2013)

          -  As ketoconazole may inhibit paclitaxel metabolism, patients receiving ketoconazole for
             any treatment indication are ineligible; patients receiving any other medications or
             substances that are inhibitors or inducers of CYP450 enzymes will be eligible;
             however, use all such medications or substances must be documented in the Case Report
             Forms

          -  For subjects assigned to take vorinostat, prior exposure to vorinostat or other known
             histone deacetylase (HDAC) inhibitors for cancer therapy; patients should not have
             taken valproic acid, another histone deacetylase inhibitor, for at least 2 weeks prior
             to study enrollment; note: this criterion does NOT apply to subjects treated on the
             Expansion Cohort (accruals post February 1, 2013)

          -  Since zidovudine and stavudine have potential for severe hematological toxicity
             potentially overlapping with toxicities of the study therapy, treatment with these
             agents will be disallowed

          -  Due to potential toxicity associated with study therapy (particularly with
             paclitaxel), patients with peripheral neuropathy > Grade 1 will be excluded from study
             participation

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, opportunistic infection, symptomatic congestive heart failure, unstable
             angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
             would limit compliance with study requirements; patients with HIV infection will be
             eligible provided they meet the criteria specified; patients with known Hepatitis B
             infection should be screened for active disease prior to study participation; patients
             with chronic Hepatitis C infection will be eligible at the discretion of the treating
             investigator

          -  Pregnant women are excluded from this study and women who become pregnant while on
             study must be immediately discontinued; women who are breastfeeding will not be
             eligible for study participation
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Missak Haigentz, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01249443

Organization ID

AMC-078

Secondary IDs

NCI-2011-02511

Responsible Party

Sponsor

Study Sponsor

AIDS Malignancy Consortium

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Missak Haigentz, Principal Investigator, AIDS Associated Malignancies Clinical Trials Consortium


Verification Date

July 2020