deltatrials
Unknown PHASE1 INTERVENTIONAL NCT00009932

Combination Chemotherapy in Treating Patients With Solid Tumors

A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors

Sponsor: National Cancer Institute (NCI)

Updated 5 times since 2017 Last updated: May 14, 2013 Started: Jan 31, 2001
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00009932, this PHASE1 trial focuses on Unspecified Adult Solid Tumor, Protocol Specific and remains ongoing. Sponsored by National Cancer Institute (NCI), it has been updated 5 times since 2001, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

OBJECTIVES: * Determine the maximum tolerated dose, clinical toxicity, and recommended phase II dose of fenretinide when combined with paclitaxel and cisplatin in patients with refractory solid tumors. * Determine the pharmacokinetics of this regimen in these patients. * Determine the therapeutic response to this regimen in these patients. OUTLINE: This is a dose escalation, multicenter study of fenretinide. Patients receive oral fenretinide twice daily on days 1-7 and paclitaxel IV over 3 hours followed by cisplatin IV over 2 hours on day 2. On day 8 of course 1, patients also receive fenretinide once in the morning. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses. Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1 year.

OBJECTIVES:

* Determine the maximum tolerated dose, clinical toxicity, and recommended phase II dose of fenretinide when combined with paclitaxel and cisplatin in patients with refractory solid tumors. * Determine the pharmacokinetics of this regimen in these patients. * Determine the therapeutic response to this regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study of fenretinide.

Patients receive oral fenretinide twice daily on days 1-7 and paclitaxel IV over 3 hours followed by cisplatin IV over 2 hours on day 2. On day 8 of course 1, patients also receive fenretinide once in the morning. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses.

Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1 year.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown

Change History

5 versions recorded
  1. Sep 2024 — Present [monthly]

    Unknown PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE1

    Status: Unknown StatusUnknown

  3. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE1

  4. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE1

  5. Jan 2017 — Jun 2018 [monthly]

    Unknown Status PHASE1

    First recorded

Jan 2001

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
  • Ohio State University Comprehensive Cancer Center
Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations