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

Part of paid clinical trials in La Jolla, California.

Sponsor
AIDS Malignancy Consortium
Study ID
NCT01249443
Phase
PHASE1
Status
Terminated

Conditions

  • HIV Infection
  • Recurrent Anal Cancer
  • Recurrent Breast Cancer
  • Recurrent Esophageal Cancer
  • Recurrent Gastric Cancer
  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • Recurrent Non-small Cell Lung Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Salivary Gland Cancer
  • Recurrent Squamous Cell Carcinoma of the Hypopharynx
  • Recurrent Squamous Cell Carcinoma of the Larynx
  • Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Recurrent Squamous Cell Carcinoma of the Nasopharynx
  • Recurrent Squamous Cell Carcinoma of the Oropharynx
  • Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Verrucous Carcinoma of the Larynx
  • Recurrent Verrucous Carcinoma of the Oral Cavity
  • Salivary Gland Squamous Cell Carcinoma
  • Stage IV Anal Cancer
  • Stage IV Breast Cancer
  • Stage IV Esophageal Cancer
  • Stage IV Gastric Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Salivary Gland Cancer
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Larynx
  • Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IV Squamous Cell Carcinoma of the Nasopharynx
  • Stage IV Squamous Cell Carcinoma of the Oropharynx
  • Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IV Verrucous Carcinoma of the Larynx
  • Stage IV Verrucous Carcinoma of the Oral Cavity
  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • vorinostat — DRUG
    Given PO
  • diagnostic laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies
  • carboplatin — DRUG
    Given IV
  • paclitaxel — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Nov 30, 2013
Status verified
Jul 2020
Primary completion
May 31, 2016
Completion
Dec 31, 2017

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (carboplatin, paclitaxel)
    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.

Primary Outcome Measure

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) [ Time Frame: 21 days ]

Locations (10)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
UCLA Center for Clinical AIDS Research and EducationLos AngelesCalifornia90035-
Lombardi Comprehensive Cancer Center at Georgetown UniversityWashington D.C.District of Columbia20057-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
John H. Stroger Jr. Hospital of Cook CountyChicagoIllinois60612-
Boston Medical CenterBostonMassachusetts02118-
Siteman Cancer Center at Washington UniversitySt LouisMissouri63110-
Montefiore Medical CenterThe BronxNew York10467-2490-
Pennsylvania Oncology Hematology AssociatesPhiladelphiaPennsylvania19106-
Benaroya Research Institute at Virginia MasonSeattleWashington98101-2795-

Find similar trials in La Jolla, CA

By condition
HIV
By specialty
Infectious disease
By research site
UC San Diego Moores Cancer Center· La Jolla, CAUCLA Center for Clinical AIDS Research and Education· Los Angeles, CALombardi Comprehensive Cancer Center at Georgetown University· Washington D.C., DCUniversity of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FLJohn H. Stroger Jr. Hospital of Cook County· Chicago, ILBoston Medical Center· Boston, MA

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