Last updated: 11/07/2018 00:48:54
A phase I study to determine the maximally tolerated dose (MTD) and sequence dependent effects of topotecan administered orally once per day for five days with a single intravenous (iv) dose of cisplatin, repeated every three weeks to subjects with malignant tumour.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A phase I study to determine the maximally tolerated dose (MTD) and sequence dependent effects of topotecan administered orally once per day for five days with a single intravenous (iv) dose of cisplatin, repeated every three weeks to subjects with malignant tumour.
Trial description: A phase I study to determine the maximally tolerated dose (MTD) and sequence dependent effects of topotecan administered orally once per day for five days with a single intravenous (iv) dose of cisplatin, repeated every three weeks to subjects with malignant tumour.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Gelderblom H, Sparreboom A, de Jonge MJA et al. An attempt to increase oral topotecan (T) dose intensity in combination with cisplatin (C): a phase I and pharmacokinetic (PK) study. Proceedings AACR, 2000; A3882.
Sparreboom A, De Jonge MJA, Loos WJ et al. Sequence-independent clinical pharmacokinetics of intravenous cisplatin and oral topotecan. Proceedings AACR, 1999; 40: A3879.
de Jonge MJA, Loos W, Gelderblom AH et al. Phase I and pharmacological study of oral topotecan and intravenous cisplatin: sequence dependent haematologic side-effects. J Clin Oncol, 2000; 18: 2104-2115.
de Jonge MJA, Sparreboom A, Planting AST et al. Oral topotecan (T) on a daily x 5 schedule in combination with intravenous cisplatin (C): a phase I and pharmacologic study in patients with advanced solid tumours. Proceedings 10th NCI-EORTC Symposium, 1998; A264.
de Jonge MJA, Sparreboom A, Planting AST et al. Sequence-dependent side effects of oral topotecan (T) with intravenous cisplatin (C) in a phase I and pharmacologic study in patients with advanced solid tumours. Proceedings ASCO, 1998; 17: A784.
Medical condition
Neoplasms, Ovarian
Product
topotecan
Collaborators
Not applicable
Study date(s)
December 1996 to January 2000
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2000-20-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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