NCT00252889

GSK - Doublet: A Phase I Study of Pegylated Liposomal Doxorubicin (Doxil) and Weekly Intravenous Topotecan in Patients With Advanced Solid Tumors

Completed Phase 1 Last updated 26 January 2009

What this trial tests

Phase 1 trial testing Topotecan and pegylated doxorubicin in Small Cell Lung Cancer in 20 participants. Completed in 1 June 2008.

Timeline

1 May 2004

Primary endpoint
1 March 2006

1 June 2008

Quick facts

Lead sponsor	Christiana Care Health Services
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 May 2004
Primary completion	1 March 2006
Estimated completion	1 June 2008
Sites	1 location across United States

Drugs / interventions tested

• Topotecan and pegylated doxorubicin — full drug profile →

Conditions studied

• Small Cell Lung Cancer — all drugs for Small Cell Lung Cancer →
• Pancreatic Cancer — all drugs for Pancreatic Cancer →
• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• Gastric Cancer — all drugs for Gastric Cancer →

Sponsor

Christiana Care Health Services — full company profile →

Who can join

18 and older, any sex, with Small Cell Lung Cancer or Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Parameters of response: tumor measurement: Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  Time frame: every other cycle
• Survival is the observed length of life from the initiation of treatment to death or the date of last contact
  Time frame: follow up until death or loss of contact
• Subjective parameters including ECOG performance status, specific symptoms, and side effects are graded according to standard Common Terminology Criteria for Adverse Events (CTCAE) v.30 criteria.
  Time frame: every cycle

Sponsor's own description

The primary objective is to determine the nature and degree of the toxicity of weekly dosing of topotecan in escalating dose levels by cohorts of 3-6 patients in combination with a fixed dose of pegylated liposomal doxorubicin (Doxil).

The secondary objective is to determine the activity of weekly topotecan and pegylated liposomal doxorubicin in advanced solid tumors.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in nanomaterials for the diagnosis and treatment of head and neck cancers: A review.
   Yu C, Li L, Wang S, Xu Y, et al · · 2023 · cited 19× · PMID 37056270 · DOI 10.1016/j.bioactmat.2022.08.010
2. Pharmacological impact of microRNAs in head and neck squamous cell carcinoma: Prevailing insights on molecular pathways, diagnosis, and nanomedicine treatment.
   Bhattacharjee B, Syeda AF, Rynjah D, Hussain SM, et al · · 2023 · cited 17× · PMID 37205904 · DOI 10.3389/fphar.2023.1174330
3. Electroporation in Head-and-Neck Cancer: An Innovative Approach with Immunotherapy and Nanotechnology Combination.
   Pisani S, Bertino G, Prina-Mello A, Locati LD, et al · · 2022 · cited 17× · PMID 36358782 · DOI 10.3390/cancers14215363
4. Nanomedicine-based adjuvant therapy: a promising solution for lung cancer.
   Xu Y, Hsu JC, Xu L, Chen W, et al · · 2023 · cited 12× · PMID 37415158 · DOI 10.1186/s12951-023-01958-4
5. Nano targeted Therapies Made of Lipids and Polymers have Promising Strategy for the Treatment of Lung Cancer.
   Essa ML, El-Kemary MA, Ebrahem Saied EM, Leporatti S, et al · · 2020 · cited 10× · PMID 33261031 · DOI 10.3390/ma13235397