Study on Veliparib and Topotecan for Treating Solid Tumors, Relapsed or Resistant Ovarian Cancer, or Primary Peritoneal Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT01012817

This clinical trial is testing the safety and best dose of two drugs, veliparib and topotecan, to see how well they work in treating patients with solid tumors, ovarian cancer that has returned or is not responding to treatment, or primary peritoneal cancer.

Patient Parameters

Program Overview

The study aims to find out if combining veliparib, which may stop tumor growth by blocking certain enzymes, with the chemotherapy drug topotecan, which kills or stops the spread of cancer cells, can effectively treat these cancers. The trial will determine the best dose and assess the treatment's effectiveness in shrinking tumors.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest and most effective dose of veliparib and topotecan for adults with advanced solid tumors. They will also look for any signs that the treatment is working against the tumors. In Phase II, the focus will be on patients with ovarian, fallopian tube, or primary peritoneal cancer to see how well the treatment works in these specific cancers.

Patients will take veliparib by mouth on specific days and receive topotecan through an IV on other days. This cycle repeats every 28 days unless the cancer progresses or side effects become too severe. After finishing the treatment, patients will have follow-up visits to monitor their health and the treatment's effects.

The study will also explore how the drugs interact in the body and whether certain genetic factors affect the treatment's success. Researchers will collect blood and urine samples to study these interactions and genetic factors.

Eligibility Criteria

Inclusion Criteria

  • Phase I: Adults with advanced solid tumors that cannot be surgically removed or cured with standard treatments.
  • Phase II: Patients with a history of ovarian, fallopian tube, or primary peritoneal cancer.
  • Must have received fewer than three previous treatments and relapsed within a year of the last platinum-based treatment.
  • Must have measurable cancer that can be tracked with scans.
  • Meet specific blood count and organ function requirements.
  • Able to provide informed consent and willing to return for follow-up visits.
  • Life expectancy of at least 12 weeks.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Able to swallow and absorb the medication.

Exclusion Criteria

  • Have a standard treatment available that could cure or extend life expectancy.
  • Previously treated with a PARP inhibitor or topotecan.
  • Have uncontrolled illnesses or conditions that would interfere with the study.
  • Have had certain treatments or therapies within a specified time before joining the study.
  • Have not fully recovered from previous treatments.
  • Have severe heart conditions or untreated brain metastases.
  • Pregnant or nursing women, or those not willing to use contraception.
  • Have other serious health conditions or active infections.
  • Have another active cancer, except for certain skin or cervical cancers.
  • Have had a heart attack or severe heart failure within the last six months.
  • Have had more than two prior chemotherapy treatments for the current cancer.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic Hospital in Arizona85054PhoenixArizona
Mayo Clinic in Arizona85259ScottsdaleArizona
University of California Davis Comprehensive Cancer Center95817SacramentoCalifornia
UCHealth University of Colorado Hospital80045AuroraColorado
Mayo Clinic in Florida32224-9980JacksonvilleFlorida
University of Chicago Comprehensive Cancer Center60637ChicagoIllinois
UC Comprehensive Cancer Center at Silver Cross60451New LenoxIllinois
University of Chicago Medicine-Orland Park60462Orland ParkIllinois
University of Kansas Clinical Research Center66205FairwayKansas
University of Kentucky/Markey Cancer Center40536LexingtonKentucky

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