Metastatic Solid TumorPhase 1NCT00611468

Phase I, Dosage-finding and PK Study of IV Topotecan and Erlotinib With Refractory Solid Tumors

A Phase 1 study testing Topotecan and Erlotinib in people with Metastatic Solid Tumor, run by Accelerated Community Oncology Research Network at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Solid Tumor
What is being tested?: Topotecan and Erlotinib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: Jun 2006to Aug 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have a histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
Prior chemotherapy must have been completed at least 3 weeks prior to enrollment (6 weeks for nitrosureas and mitomycin) and the patient must have recovered from all associated toxicities (except alopecia and neuropathy grade 1 according to the NCI-CTC, version 3.0 classification). Radiation must have been completed 8 weeks prior to enrollment. Major surgery must have been completed 4 weeks prior to enrollment. Hormonal therapy must have been completed at least 2 weeks prior.
Age >18 years.
ECOG performance status <1 (Karnofsky >70%)
Life expectancy of greater than 12 weeks.
Patients must have normal organ and marrow function as defined below: White blood cell count >2,500/mm3, Absolute neutrophil count (ANC) >1,500/ mm3, Platelet count >100,000/ mm3, Hemoglobin > 10 g/dL, Albumin >2.5 g/dL, Total bilirubin <1.5 X institutional upper limit of normal (ULN), AST/ALT <1.5 X institutional ULN, Serum creatinine <2.0 g/dL, Creatinine clearance >40 mL/min

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Patients must be able to swallow and retain oral medication
Female patients must be nonpregnant and nonlactating. All patients of childbearing potential must implement an effective method of contraception during the study. All female patients (except those who are postmenopausal or surgically sterilized) must have a negative pre-study serum or urine pregnancy test obtained within 7 days of study enrollment.
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Who cannot join

Patients may not be receiving any other investigational agents. Participation in other clinical trials with any investigational drugs must have been completed ≥ 28 days prior to enrollment on this trial (or longer based on the halflife of the investigational agent).
Patients must have no more than 3 prior lines of therapy. The patient may have only received carboplatin and/or gemcitabine in one of the prior lines of therapy.
Patients must not be receiving concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy for cancer). Low dose maintenance steroids are acceptable if the patient will remain on a stable dose during cycles 1, 2 and 3 (to ensure continuity for topotecan pharmacokinetic studies).
Patient may not have a history of serious allergic reactions attributed to compounds of similar chemical composition to topotecan (camptothecins) and/or erlotinib (tyrosine kinase inhibitors).
Patients must not have malabsorption syndrome, any disease significantly altering gastrointestinal function, or resection of the stomach or small bowel.
Patients must not be taking warfarin (including low dose anticoagulants).

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Patients must not be taking concurrent treatment with potent inhibitors of cytochrome P450 3A4. For patients who were receiving treatment with such agents, a one-week washout period is required prior to beginning the protocol.
Patients must not be taking concurrent treatment with potent inducers of cytochrome P450 3A4, such as phenytoin, carbamazepine, rifampin, barbiturates, or St. John's Wort. For patients who were receiving treatment with such agents, a one week washout period is required prior to beginning the protocol.
Patients must have no active serious infection, fever > 38.2 degrees Celsius, or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment (i.e., documented HIV infection, uncontrolled hypertension, uncontrolled CNS metastases, unstable angina, congestive heart failure, poorly controlled diabetes, coronary angioplasty within 6 months, myocardial infarction within 6 months, uncontrolled atrial or ventricular arrhythmias).
Patients should not have psychological, familial, sociological geographical conditions that do not permit medical follow-up and compliance with the study protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

The West Clinic
Memphis, Tennessee, 38120

Other trials in United States

About this study

Official title: A Phase I, Dosage-finding and Pharmacokinetic Study of Intravenous Topotecan and Oral Erlotinib in Adults With Refractory Solid Tumors

The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib.

Read the detailed description

The primary objectives of this trial include:

To determine the maximum tolerated dosage (MTD) of intravenous topotecan when given in combination with oral erlotinib.
To define the dosage-limiting toxicities (DLT) of this combination.
To evaluate the pharmacokinetic (PK) parameters of intravenous topotecan with and without erlotinib

The secondary objectives include:

To evaluate the pharmacodynamic effect of the topotecan and erlotinib combination
To evaluate for any correlations between the presence of CYP3A4/5 polymorphisms and topotecan / erlotinib disposition and to measure the frequency of MDR1 and BCRP in peripheral blood samples and correlate these results with topotecan pharmacokinetics
To measure the frequency of UGT genotypes in peripheral blood samples
To evaluate the objective response rate using the RECIST criteria.

Conditions: Metastatic Solid Tumor
Being tested: Topotecan, Erlotinib
Medical subject headings: Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TopotecanDrug
Also called Hycamtin
All subjects receive treatment with intravenous topotecan and oral erlotinib.
ErlotinibDrug
Also called Tarceva
All subjects receive treatment with intravenous topotecan and oral erlotinib.

Study groups in NCT00611468
Study group	Role	What they receive
Intravenous Topotecan and Oral Erlotinib	Experimental	All subjects receive treatment with intravenous topotecan and oral erlotinib. Receives: Drug: Topotecan; Drug: Erlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Tolerated Dosage (MTD) of Intravenous Topotecan When Given in Combination With Oral Erlotinib
The MTD of topotecan was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience a DLT at a given dosage level, 3 patients are enrolled at the same dosage level.
Measured: MTD was assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21).
Dosage Limiting Toxicities
Measured: DLT were assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21)
Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Mean Clearance)
Measured: Day 1 Week 1 and Day 1 Week 3
Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Renal Clearance)
Measured: Day 1 Week 1 and Day 1 Week 3
Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Dose-Normalized AUC)
Measured: Day 1 Week 1 and Day 1 Week 3

Secondary outcomes (2)

Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
Each subgroup lists the gene on which a polymorphism occurred (e.g., CYP3A4), the name of the polymorphism (e.g., *1), whether it was heterozygous or a variant, the number of subjects with available data, and the number who had the polymorphism.
Measured: Baseline
Objective Response (as Determined Using RECIST 1.0 Criteria)
Measured: Every 6 weeks until the end of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Aug 2009

First posted11 Feb 2008 (estimated)
Study startJun 2006
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00611468
Sponsor's protocol ID: ACORN ALSSRST0501
Status last verified: Aug 2011
First submitted: 29 Jan 2008
Last updated: 22 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors

All Metastatic Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Dosage-finding and Pharmacokinetic Study of Intravenous Topotecan and Oral Erlotinib in Adults With Refractory Solid Tumors
ClinicalTrials.gov ID: NCT00611468
Acronym / sponsor ID: ACORN ALSSRST0501
Conditions: Metastatic Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Accelerated Community Oncology Research NetworkUniversity, hospital or other
Collaborators: GlaxoSmithKline, Genentech, Inc.
Study start: Jun 2006
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 11 Feb 2008 (estimated)
Results: Posted 19 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib.

Detailed description

The primary objectives of this trial include:

To determine the maximum tolerated dosage (MTD) of intravenous topotecan when given in combination with oral erlotinib.
To define the dosage-limiting toxicities (DLT) of this combination.
To evaluate the pharmacokinetic (PK) parameters of intravenous topotecan with and without erlotinib

The secondary objectives include:

To evaluate the pharmacodynamic effect of the topotecan and erlotinib combination
To evaluate for any correlations between the presence of CYP3A4/5 polymorphisms and topotecan / erlotinib disposition and to measure the frequency of MDR1 and BCRP in peripheral blood samples and correlate these results with topotecan pharmacokinetics
To measure the frequency of UGT genotypes in peripheral blood samples
To evaluate the objective response rate using the RECIST criteria.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intravenous Topotecan and Oral Erlotinib	Experimental	Drug: Topotecan, Drug: ErlotinibAll subjects receive treatment with intravenous topotecan and oral erlotinib.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients must have a histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
Prior chemotherapy must have been completed at least 3 weeks prior to enrollment (6 weeks for nitrosureas and mitomycin) and the patient must have recovered from all associated toxicities (except alopecia and neuropathy grade 1 according to the NCI-CTC, version 3.0 classification). Radiation must have been completed 8 weeks prior to enrollment. Major surgery must have been completed 4 weeks prior to enrollment. Hormonal therapy must have been completed at least 2 weeks prior.
Age >18 years.
ECOG performance status <1 (Karnofsky >70%)
Life expectancy of greater than 12 weeks.

Key exclusion criteria (10 listed)

Patients may not be receiving any other investigational agents. Participation in other clinical trials with any investigational drugs must have been completed ≥ 28 days prior to enrollment on this trial (or longer based on the halflife of the investigational agent).
Patients must have no more than 3 prior lines of therapy. The patient may have only received carboplatin and/or gemcitabine in one of the prior lines of therapy.
Patients must not be receiving concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy for cancer). Low dose maintenance steroids are acceptable if the patient will remain on a stable dose during cycles 1, 2 and 3 (to ensure continuity for topotecan pharmacokinetic studies).
Patient may not have a history of serious allergic reactions attributed to compounds of similar chemical composition to topotecan (camptothecins) and/or erlotinib (tyrosine kinase inhibitors).
Patients must not have malabsorption syndrome, any disease significantly altering gastrointestinal function, or resection of the stomach or small bowel.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TopotecanAlso: HycamtinAll subjects receive treatment with intravenous topotecan and oral erlotinib.	Drug	Intravenous Topotecan and Oral Erlotinib
ErlotinibAlso: TarcevaAll subjects receive treatment with intravenous topotecan and oral erlotinib.	Drug	Intravenous Topotecan and Oral Erlotinib

Primary outcome

Maximum Tolerated Dosage (MTD) of Intravenous Topotecan When Given in Combination With Oral Erlotinib
Time frame: MTD was assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21).
The MTD of topotecan was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience a DLT at a given dosage level, 3 patients are enrolled at the same dosage level.
Dosage Limiting Toxicities
Time frame: DLT were assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21)
Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Mean Clearance)
Time frame: Day 1 Week 1 and Day 1 Week 3
Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Renal Clearance)
Time frame: Day 1 Week 1 and Day 1 Week 3
Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Dose-Normalized AUC)
Time frame: Day 1 Week 1 and Day 1 Week 3

2 secondary outcomes

Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)
Time frame: Baseline
Objective Response (as Determined Using RECIST 1.0 Criteria)
Time frame: Every 6 weeks until the end of study treatment

Results and safety

Results posted to the registry on 19 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dosage Level 1 for MTD Determination	3	3
Dosage Level 2 for MTD Determination	7	6
Dosage Level 3 for MTD Determination	6	6
PK Group for Additional PK Data	13	13

Primary outcome: Maximum Tolerated Dosage (MTD) of Intravenous Topotecan When Given in Combination With Oral Erlotinib

Time frame: MTD was assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21).. Number. Unit: mg/m^2

Measure	Treatment Group: Intravenous Topotecan and Oral Erlotinib n = 15
Value	1.0

Population analysed: DLT information was available for 3 patients who received a topotecan dose of 0.75 mg/M\^2, for 6 patients who received a topotecan dose of 1.0 mg/M\^2, and for 6 patients who recived a topotecan dose of 1.25 mg/M\^2. 1 additional patient received a dose 1.0 mg/M\^2 but withdrew before completing cycle 1. This patient had no DLT and was replaced.

Primary outcome: Dosage Limiting Toxicities

Time frame: DLT were assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21). Number. Unit: Participants

Measure	Treatment Group: Intravenous Topotecan and Oral Erlotinib n = 28
Dose Level 1 (N = 8)	1
Dose Level 2 (N = 14)	5
Dose Level 3 (N = 6)	2

Population analysed: DLT were assessed using NCI CTCAE version 3.0. After MTD was determined, 13 additional patients were enrolled to enhance estimation of PK parameters. The first 8 were enrolled at dose 2. Because 4 of these patients experienced a DLT, the remaining 5 patients were enrolled at dose level 1. Of these, 1 experienced a DLT.

Primary outcome: Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Mean Clearance)

Time frame: Day 1 Week 1 and Day 1 Week 3. Mean (Standard Deviation). Unit: L/h/m^2

Measure	Treatment Group: Intravenous Topotecan and Oral Erlotinib n = 18
Without Erlotinib	9.41 (3.40)
With Erlotinib	8.60 (3.04)

Population analysed: Of the 29 consenting patients, 18 provided information that could be used in the analysis. 1 patient withdrew, 2 had samples that were inevaluable due to lab error, and 8 went off study before receiving topotecan with erlotinib.

Primary outcome: Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Renal Clearance)

Time frame: Day 1 Week 1 and Day 1 Week 3. Mean (Standard Deviation). Unit: L/h/m^2

Measure	Treatment Group: Intravenous Topotecan and Oral Erlotinib n = 13
Without Erlotinib	4.95 (2.38)
With Erlotinib	4.07 (1.87)

Population analysed: Of the 29 consenting patients, 18 provided information that could be used in the analysis. However, only 13 were able to be analyzed for the renal clearance because in 5 patients the amount of topotecan measured in the urine was more than the topotecan dose that was given. Renal clearance was not calculated for those patients.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group: Intravenous Topotecan and Oral Erlotinib	11 of 29 (37.9%)	29 of 29 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metastatic Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lee S. Schwartzberg, MD, FACP principal investigator

Accelerared Community Oncology Research Network, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Topotecan and Erlotinib in people with Metastatic Solid Tumor, run by Accelerated Community Oncology Research Network at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dosage (MTD) of Intravenous Topotecan When Given in Combination With Oral Erlotinib (time frame: MTD was assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00611468.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2011.