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NCT03930771 · OUTCOME

Effect of the CAP and TMZ Combination on Pituitary Function, Measured by Changes in Pituitary Hormone Secretion in Patients

Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas · Source last updated 2022-08-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
ng/mL
Interval / dispersion
Not reported
Time frame
At baseline and every 8 weeks, up to 6 months

What was measured

Serum prolactin, IGF-1, ACTH, FSH, LH and TSH levels are used to assess changes in pituitary hormone function. These tests will only be repeated if found to be abnormal at baseline.

Groups in this outcome

All Patients

All subjects will receive: 1. Capecitabine (oral 5-Fluorouracil) 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. 2. Temozolomide (second generation alkylating agent) 150 to 200 mg/m2 orally on days 10 through 14. After completion of 6 cycles, patients achieving a complete or partial tumor response may continue to receive capecitabine temozolomide at the investigator's discretion in the absence of disease progression or unacceptable toxicity. Patients will be monitored for six months after they come off the study (either after completing 6 cycles or in setting of disease progression or unacceptable toxicity). Capecitabine: 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. Temozolomide: 150 to 200 mg/m2 orally on days 10 through 14.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All Patients1

Reported measurements

Baseline
Values in ng/mL · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients134.7Not reportedNot reportedNot reportedNot reported
Cycle 3 Day 1
Values in ng/mL · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients86.9Not reportedNot reportedNot reportedNot reported
Cycle 5 Day 1
Values in ng/mL · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients69.4Not reportedNot reportedNot reportedNot reported
Cycle 6 Day 1
Values in ng/mL · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients69.8Not reportedNot reportedNot reportedNot reported
End of Treatment
Values in ng/mL · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients80.1Not reportedNot reportedNot reportedNot reported
Follow-Up Week 6
Values in ng/mL · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients77.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        134.7
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        86.9
    title
    Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        69.4
    title
    Cycle 5 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        69.8
    title
    Cycle 6 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        80.1
    title
    End of Treatment
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        77.0
    title
    Follow-Up Week 6
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
Serum prolactin, IGF-1, ACTH, FSH, LH and TSH levels are used to assess changes in pituitary hormone function. These tests will only be repeated if found to be abnormal at baseline.
groups
  1. description
    All subjects will receive: 1. Capecitabine (oral 5-Fluorouracil) 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. 2. Temozolomide (second generation alkylating agent) 150 to 200 mg/m2 orally on days 10 through 14. After completion of 6 cycles, patients achieving a complete or partial tumor response may continue to receive capecitabine temozolomide at the investigator's discretion in the absence of disease progression or unacceptable toxicity. Patients will be monitored for six months after they come off the study (either after completing 6 cycles or in setting of disease progression or unacceptable toxicity). Capecitabine: 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. Temozolomide: 150 to 200 mg/m2 orally on days 10 through 14.
    id
    OG000
    title
    All Patients
param Type
NUMBER
reporting Status
POSTED
time Frame
At baseline and every 8 weeks, up to 6 months
title
Effect of the CAP and TMZ Combination on Pituitary Function, Measured by Changes in Pituitary Hormone Secretion in Patients
type
SECONDARY
unit Of Measure
ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice